India & Access

04/03/2013 07:39 AM |

The biggest canard surrounding the Indian Supreme Court’s refusal to grant Novartis a patent for Gleevec is that it will create “access.”

Let’s put the rhetoric aside and look at the facts.

1- The Government of India ranks below sub-Saharan Africa and near the bottom of all 170+ countries included in the WHO World Medicines Report in terms of GDP spend on publicly funded drug programs that serve vulnerable populations.

2- India is one of the few countries in the world that collects more on taxes and tariffs for medicines than it spends on providing medicines to the poor.  Broad analysis for 2011 indicates that total annual government expenditure on drugs in India was around $1.15B in comparison to the $1.22B it received in taxation of pharmaceuticals.

3- CIPLA, an Indian generic company that was part of the Gleevec patent case, has nearly $300 million in unpaid fines for overcharging for essential medicines in India.

Make no mistake – the Novartis case wasn’t about access. It was (and is) about domestic industrial policy.

Who will India is send to BIO this year? And how will they address the concerns of jittery investors and prospective partners?

  Read More & Comment...

The Warren Report

04/02/2013 08:58 AM |

Medical device taxation and New York Times misrepresentation.

In an otherwise misguided editorial condemning the Senate’s bipartisan (79-20) call to repeal the medical device tax, the New York Times writes, “One of the signers was Ms. Warren of Massachusetts ... Ms. Warren wrote that the tax stifles innovation, research and development. That’s a high-minded justification.”

Indeed it is. And she’s right.

  Read More & Comment...

India Ink

04/01/2013 09:52 AM |

India -- a nation known for its innovation in many areas -- has decided that incremental innovation in pharmaceuticals isn't important -- at least when it comes to patent protection.

The Supreme Court of the world’s largest democracy has rejected Novartis’ attempt to patent the cancer treatment Gleevec. But what the India has really rejected is medical innovation. And what activists are applauding as a road to broader patient access is a phony and pyrrhic ruling.

Citing a legal provision in India's 2005 patent law aimed at preventing companies from getting fresh patents for making only minor changes (“evergreening”), India's patent office didn't issue a fresh patent for the medicine because it was not a new medicine but an amended version of its earlier product. But what makes this ruling even more absurd is that Novartis wasn't asking for a patent on an incremental innovation -- their request was for a beta crystal reformulation to make the existing product more stable.

In other words, Gleevec isn’t innovative enough for India.

According to the New York Times, "The court's ruling confirmed that India's criteria for the granting of such patents remain far higher than those in the United States, where patents are so easy to win that one was given in 1999 for a peanut butter-and-jelly sandwich."

That’s a nice anecdote but as the saying goes, the plural of “anecdote” isn’t “data.” What does the Indian decision mean?

It means the Indian court doesn’t understand how pharmaceutical innovation happens – or why it’s relevant. As any medical scientist will tell you, there are few "Eureka!" moments in health research. Progress comes step-by-step, one incremental innovation at a time. Even the smallest innovations are made only after large amounts of very expensive research is done.

Once a lifesaving drug or treatment exists, it’s seductively easy to take it for granted. We sometimes forget the years of toil these things take to develop; the millions spent to bring a new drug or treatment from theory to actuality.

Abraham Lincoln wrote, patents “add the fuel of interest to the passion of genius.”

There is a reason why virtually all the world’s “miracle drugs” have been developed in Western countries. It’s called incentive. Because innovation is honored and protected and inventors are rewarded for their work.

Where there there is no patent protection there is no investment.  And where there is no investment there is no innovation.

Minus patent protection, an innovator company can't earn back what it invested in R&D, ergo they can't reinvest their profits in further R&D -- further delaying crucial incremental innovation which is how medical progress is made.

(But large Indian generic manufacturers can make a bundle.)

Not surprisingly, the usual suspects of so-called “civil society” are trumpeting the Indian decision as a victory for patient access. Nonsense. Price isn’t the problem.

Obvious by its omission is the fact that about 99% of all the Gleevec in India is given for free. Patents have not prevented access. In fact, when you examine the WHO’s model Essential Drug List, very few of the 400 or so drugs deemed essential are new or patented or were ever patented in the world’s poorest countries.  In category after category, from aspirin to Zithromax, in almost every case and in almost every country, these medicines have always been (or have been for many years) in the public domain.  That is, the medicine is fully open to legal and legitimate generic manufacture. And yet there still isn't broad patient access.

If we allow our emotions (and sloppy reporting) to trump reason, we’ll end up with a lot less innovation.

And fewer lifesaving drugs to take for granted.

The Indian decision is a horrible blow to global public health -- and particularly to the Third World, because economically-driven, short-term decisions have deadly unintended consequences.   Read More & Comment...

Boogie on down to BIO

03/29/2013 09:18 AM |

Join me, Jim DiBiasi (Partner, 3D Communications), Tony Russo (Chairman and CEO Russo Partners), Howard Yuwen (Executive Director, Regulatory Affairs, Alexixon, and moderator David Schull (President, Russo Partners) for a must attend panel discussion:

Thriving, Not Just Surviving: FDA Advisory Committee Meetings

2:30 PM - 3:30 PM on Monday, Apr 22, 2013

Location Building: N426A

Description

For many biotech executives, the term "FDA advisory committee meeting" evokes feelings of fear, even among those with historical experience. Instead of tackling Advisory Committee (Ad Com) hearings as times of opportunity in which their companies can thrive, too many executives are focused on survival. Yet, the fate of their drugs in development can rest heavily on the decisions the FDA's outside advisors. In this dialogue, biopharma executives and industry experts review lessons learned from past experiences, as well as what best practices participants can apply to get ready for and succeed in the advisory committee environment. 

Learning Objectives:

• Discuss the integration needed for medical/regulatory affairs for Ad Com success
• Identify necessary and beneficial steps to prepare your company for Ad Com interaction
• Examine lessons learned from a recent case study

Ability Level: Advanced

Learning Objectives:

• Discuss the integration needed for medical/regulatory affairs for Ad Com success
• Identify necessary and beneficial steps to prepare your company for Ad Com interaction
• Examine lessons learned from a recent case study

  Read More & Comment...

Science Is Often a Kick in the Gut

03/28/2013 02:07 PM |

Science, at least science shaped by clinical observation and the elucidation of disease mechanisms continue to surprise. In particular, this occurs when treatments bump up against the microbiome.. Obese people considering gastric bypass surgery to help trim their fat might one day have another option: swallowing a new supply of gut bacteria. A study in mice suggests that weight loss after bypass surgery is caused not by the operation itself, but at least in part by a change in the amounts of various species of microbes in the gut. A bypass operation separates off a small part of the stomach and connects that directly to the intestines. Recipients tend to feel less hungry, fill up more quickly and burn more calories at rest, and they often lose up to 75% of their excess fat. Counter-intuitively, this is thought to be caused by a change in metabolism, rather than by the reduced size of the stomach. Gut microbes are thought to be part of this picture. People who have had bypasses are known to experience changes in the selection of microbes in their guts. Fat people have been shown to host a different selection of gut bacteria from people who are obese, and transferring the gut bacteria of fat mice into thin ones can cause the thin mice to pack on extra weight. But no one knew whether the microbes in bypass patients changed because they got thin, or if the patients got thin because the microbes changed. Chop and change To investigate, Lee Kaplan, director of the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital in Boston, and his colleagues gave about a dozen obese mice bypass surgery. As expected, the mice lost about 29% of their body weight, and kept it off despite a high-fat diet. New conditions in their bodies — such as a change in bile acids — allowed a different set of gut bacteria to thrive. The researchers then took faecal samples from the mice that had been operated on, and put bacteria from them into the guts of mice specially bred without any gut flora. These mice, which were not obese, lost 5% of their weight without any changes to their diet. The results are reported in Science Translational Medicine. The effect is impressively large, says Randy Seeley, an obesity researcher at the University of Cincinnati in Ohio, particularly given that sterile mice almost always gain weight when given any kind of gut flora. The fact that the mice getting the second-hand bacteria did not lose as much weight as those that had surgery suggests that other factors are also at work; these could include hormonal changes. The results are promising for obesity treatments, but there are still hurdles to overcome. “You can’t just take a pill of the right bacteria and have them stick around,” says Seeley. If the gut’s environmental conditions don’t change, then the original microbes come back, he says. Kaplan says that the next steps are to isolate the four bacteria types that the study found to be at play and introduce them into obese mice or people. Antibiotic treatments might help the new bacteria to stick. “I believe it’s possible,” says Kaplan. This article is reproduced with permission from the magazine Nature. The article was first published on March 27, 2013.  Read More & Comment...

Deseret News

03/28/2013 10:12 AM |

Government (aka “academic”) detailers calling on physicians in Utah will now have to play by the same rules as pharmaceutical representatives. Governor Gary Herbert has just signed into law H.B. 120 (“Information on Pharmaceutical Products”), a bill that “amends the Division of Occupational and Professional Licensing Act related to commercial and academic detailing for prescription drugs.”

This bill “creates standards for providing educational information to health care providers about prescription drugs” and “expands the application of federal regulations that apply to a pharmaceutical manufacturer's drug representatives to other health care providers who make educational statements about a prescription drug.”

Specifically, “An academic detailer and a commercial detailer who educate another health care provider about prescription drugs through written or oral educational material is subject to federal regulations regarding:

(i) false and misleading advertising in 21 C.F.R., Part 201 (2007);

(ii) prescription drug advertising in 21 C.F.R., Part 202 (2007); and

(iii) the federal Office of the Inspector General's Compliance Program Guidance for Pharmaceutical Manufacturers issued in April 2003, as amended.”

Utah, land of the Bonneville Salt Flats, isn’t passing judgment on academic detailing; they’re just leveling the playing field. Unlike the AAMC (which believes that Uncle Sam isn’t subject to conflict of interest when it comes to the sharing of medical information), the Beehive State has their eyes open. Detailing is Detailing is Detailing.

The Information on Pharmaceutical Products Act makes the common sense point that, without public scrutiny there is no guarantee that government-sponsored detailing will present information that is unbiased, peer-reviewed, and aligned with the existing evidence base. Without clear guidelines, there is nothing to prevent government detailers from using their outreach to advocate instead of educate.

Previous government detailing efforts have often focused on demonstrating their own value by highlighting the cost effectiveness of initiatives through savings generated from the increased utilization of generics and other low cost therapies.

Asked another way – how can an “academic detailing” program funded by our nation’s largest payer (Uncle Sam) be considered neutral? Just like detailing programs run by pharmaceutical companies, there is an inherent “interest.” And that’s okay – as long as that “interest” is transparent.

Fairness is the proper yardstick. The general lack of rules or oversight stands in stark contrast to the extreme scrutiny with which industry “detailers” are subject in their interactions with physicians. Starting with the Federal Food, Drug, and Cosmetic Act of 1938, and continuing through the 2010 FDA “Bad Ad Program,” the federal government has imposed a number of regulations on industry’s ability to promote their products and distribute information about their drugs to physicians and consumers. Rightfully so.

And now the government’s detailers must play by the same rules – at least in Utah.

It’s a good first step.

Government-funded detailers should be held to the same standard as industry representatives in every state. This simple, common sense step would ensure providers are receiving accurate, unbiased information on the best treatment options available to improve patient care.

A number of unanswered questions remain. For example, if government detailers stray into off-label conversations, to whom does FDA’s Office of Prescription Drug Promotion send a letter? Whom does the Department of Justice investigate? Who pays the fine?

That’s a good point of departure for a conversation between AHRQ and the FDA – both agencies within the US Department of Health and Human Services.

  Read More & Comment...

Wyden: Asked and Answered

03/27/2013 09:11 AM |

As previously discussed (“Wyden Open Spaces”), Senator Ron Wyden (D-OR.) sent a letter to NIH requesting a list of medicines that have reached the market as result of NIH research since 1995 -- when the agency removed the reasonable pricing clause from cooperative research and development agreements (CRADAs). Wyden also asked NIH to convene a panel to reexamine the pricing of medicines and treatments that are developed with public funding.

He’s made this request before. Maybe he should actually read what the NIH has already said on the matter.  Here it is straight from the NIH’s Office of Technology Transfer:

Requiring direct financial recoupment of the federal investment in biomedical research can potentially impede the development of promising technologies by causing industry to be unwilling to license federally funded technologies. The “reasonable pricing” provisions that NIH once required in all CRADA and exclusive license negotiations did just that. Of even greater concern should be the potential that the economic disincentives of recoupment will make it expedient for industry to move research outside the federal milieu. Such action would diminish the strides made under the Bayh-Dole Act and have the unintended consequence of removing the research from federal oversight, a particular concern when the research involves lines of investigation that are especially critical or sensitive.  

It is impossible to overstate the achievements or the global macroeconomic impact of U.S. taxpayer-supported biomedical research. Federally funded biomedical research, aided by the economic incentives of Bayh-Dole, has created the scientific capital of knowledge that fuels medical and biotechnology development. American taxpayers, whose lives have been improved and extended, have been the beneficiaries of the remarkable medical advances that have come from this enterprise.

Senator Wyden’s misinformed inquiry brings to mind a quote from Robert Louis Stevenson:

“Politics is perhaps the only profession for which no preparation is thought necessary.”

  Read More & Comment...

Importation Agonistes

03/26/2013 08:31 AM |

The only thing that dies harder than a bad idea is a bad idea with political resonance.

And one of the down sides of term-limited state legislators is that bad ideas keep getting resurrected. Case in point: state-sponsored schemes for drug importation.

As a public service to these newly elected members, a brief primer on why drug importation is a bad idea There are four basic reasons:

(1) It doesn’t save money.

(2) The drugs being sent to U.S. customers from Canadian Internet pharmacies are not “the same drugs Canadians get.”

(3) The state experience has been dismal and politically embarrassing.

(4) National Security concerns.

Let’s look at each of these four items.

(1) It won’t save any money. Let’s not forget the non-partisan CBO study that showed that such policy would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.

(2) The drugs being sent to U.S. customers from Canadian internet pharmacies are not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. In fact, drugs sold to Americans by Canadian Internet pharmacies aren’t even legal for sale in Canada. This isn’t about the quality of Canadian drug regulation. Canadian Internet pharmacies – by their own admission – are sourcing the drugs they're sending to the United States from outside of Canada. And while they may say their drugs come from Great Britain, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.

And the important political point here is that when Americans are asked if they want drugs from nations other than Canada – the answer is a resounding “no thank you.”

(3) The state experience has been dismal and politically embarrassing. Remember Illinois’ high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population.

And what of Minnesota’s RxConnect program? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.

That'ss not a surprise considering that Minnesota, state officials observed Canadian Internet pharmacies engaging in dangerous practices.

One pharmacy had its pharmacists check 100 new prescriptions or 300 refill prescriptions per hour, a volume so high that there is no way to assure safety.

One pharmacy failed to label its products and several others failed to send any patient drug information to patients receiving prescription drugs.

Drugs requiring refrigeration were being shipped un-refrigerated with no evidence that the products would remain stable.

One pharmacy had no policy in place for drug recalls. Representatives of the pharmacy allegedly said that the patient could contact the pharmacy about a recall "if they wished."

The FDA launched an investigation, confiscating thousands of drug shipments headed for the United States. Some of them were headed for Minnesotans who ordered them over the state's Web site.

When opened, nearly half claimed to be of Canadian origin, but "85 percent of them were from 27 other countries including Iran, Ecuador and China." And 30 of them were counterfeit.

One Minnesota resident discovered that one of his "Canadian" drugs came from Greece, and another came from Vanuatu, a small island in the South Pacific. "I never heard of the place," he said.

Wisconsin also has an importation program, modeled on the one in Minnesota. It too hawks its promise and hides its dangers. All of the legalese buries the fact that the state doesn't accept any responsibility for the safety or effectiveness of any medicines bought on the state's Web site.

The state won't even guarantee that the drugs ordered are what the customer will receive. Not only that, but the state also says that it will not accept any legal responsibility or liability should any of the drugs cause a problem.

And remember Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield is now out of the drugs from Canada business.

(4) National Security concerns. According to a report from the federal Joint Terrorism Task Force, a global terrorist ring with ties to Hezbollah, is importing counterfeit drugs into America by way of Canada. They are doing so for profit today - but could just as easily do so for more nefarious and deadly purposes. And legalizing importation would only facilitate such actions.

And then there are those politically pesky safety issues.

Adding fuel to the reality is a new by the European Alliance for Access to Safe Medicines.  The title says it all, “The Counterfeiting Superhighway.”

The report reveals the scope of the unregulated trade of fake pharmaceuticals. Through extensive research and examination of over 100 online pharmacies and over 30 commonly purchased prescription-only medicines, the report makes one thing very clear – we’re not winning the battle.

Key findings from this report

* 62% of medicines purchased online are fake or substandard (including medicines indicated to treat serious conditions such as cardiovascular and respiratory disease, neurological disorders, and mental health conditions).

* 95.6% of online pharmacies researched are operating illegally.

* 94% of websites do not have a named, verifiable pharmacist.

* Over 90% of websites supply prescription-only medicines without a prescription.

* 78.8 of websites violate intellectual property.

My favorite anecdote is the report’s example of an Internet pharmacy whose products came wrapped in pages from the Mumbai Daily News.  The most frightening fact, though, is most of the fake medicines “were delivered in seemingly authentic boxes, accompanied by patient information leaflets in good condition and ostensibly trustworthy blister packs.”

Novice state legislators considering drug importation should refer to Bartlett's Familiar Quotations:

"Those who cannot learn from history are doomed to repeat it."

  Read More & Comment...

David Vitter: Patent Pending

03/22/2013 09:14 PM |

David Vitter: Wrong on Drug Importation. Wrong on Patent Settlements.

This overly vague language of Senator Vitter’s amendment (#628) to the Senate Budget Resolution would ban all forms of patent settlements, including those that the FTC and the courts have not opposed. This would prevent pro-consumer settlements, reduce the value of patents, and reduce incentives for innovation.  Instead, enforcement agencies and courts should continue to evaluate patent settlements on a case-by-case basis, under the same antitrust principles that apply to all other patent settlements.

The Supreme Court is currently addressing the issue, and Congress should await the Court’s ruling (likely this June) on the standard for reviewing such settlements.

For the first time the Supreme Court will review a case regarding the antitrust standard that should apply to patent settlements between innovator and generic pharmaceutical companies.  Given the complexities and the conflict between the circuits, even if legislators believe that Congressional action may be warranted, consideration of the issue should await the Supreme Court’s decision in the case. 

A ban is bad public policy that harms innovation.

Banning Hatch-Waxman patent settlements would increase the cost of patent enforcement, decrease the value of patent protection generally, and decrease incentives for taking the risks necessary to develop new medicines.  As one court has stated, “a rule prohibiting settlements of Hatch-Waxman litigation can have grave consequences for R&D and, in turn, severe consequences for consumers.”

A ban would delay generic entry and delay benefits to consumers. 

Despite what proponents of the legislation say, statistics show that brand companies have prevailed in approximately 52 percent of patent cases against generic challengers.

A win by the patent holder means the generic almost certainly would not be able to enter the market before the patent expires.  In many cases, therefore, settlements accelerate generic entry and provide access to lower cost medicines.  According to one generic company’s estimate, settlements on 10 products alone have resulted in more than $67 billion in savings to consumers. 

Congress has already given the Federal Trade Commission the ability to review and evaluate individual patent settlements. 

Unlike patent settlements in any other industry, Congress in 2003 required that brand and generic companies settling patent litigation arising out of the generic company’s patent challenge must file a copy of their settlement agreement or a written description of it with the FTC and the Department of Justice before the date when the generic product may enter the market.  The FTC thus has the power to challenge any agreement that it deems anticompetitive. 

A ban on an entire category of settlements is unwarranted.  This kind of blanket ban is overly broad and could negatively impact the availability of medicines that help patients live longer, healthier lives.

  Read More & Comment...

If want to keep your insurance you can ...

03/22/2013 08:20 AM |

... If you can afford it.

Health Insurers Warn on Premiums

By ANNA WILDE MATHEWS and LOUISE RADNOFSKY

Health insurers are privately warning brokers that premiums for many individuals and small businesses could increase sharply next year because of the health-care overhaul law, with the nation's biggest firm projecting that rates could more than double for some consumers buying their own plans.

The projections, made in sessions with brokers and agents, provide some of the most concrete evidence yet of how much insurance companies might increase prices when major provisions of the law kick in next year—a subject of rigorous

UnitedHealth Group, the nation's largest carrier, and other health insurers said premiums for some individuals and small businesses could rise.

The projected increases are at odds with what the Obama Administration says consumers should be expecting overall in terms of cost. The Department of Health and Human Services says that the law will "make health-care coverage more affordable and accessible," pointing to a 2009 analysis by the Congressional Budget Office that says average individual premiums, on an apples-to-apples basis, would be lower.

The gulf between the pricing talk from some insurers and the government projections suggests how complicated the law's effects will be. Carriers will be filing proposed prices with regulators over the next few months.

Part of the murkiness stems from the role of government subsidies. Federal subsidies under the health law will help lower-income consumers defray costs, but they are generally not included in insurers' premium projections. Many consumers will be getting more generous plans because of new requirements in the law. The effects of the law will vary widely, and insurers and other analysts agree that some consumers and small businesses will likely see premiums go down.

Starting next year, the law will block insurers from refusing to sell coverage or setting premiums based on people's health histories, and will reduce their ability to set rates based on age. That can raise coverage prices for younger, healthier consumers, while reining them in for older, sicker ones. The rules can also affect small businesses, which sometimes pay premiums tied to employees' health status and claims history.

The law's 2014 effect on larger companies is likely to be more limited. Many of the big changes coming next year won't touch them as directly as individual consumers and small businesses, though some will have to grapple with the cost of covering more workers or paying a penalty.

The possibility of higher premiums has become the latest focal point of the political tussle over the health law, which marks its third anniversary Saturday. Republican lawmakers have held hearings on the issue, and six GOP members of the House Energy and Commerce committee wrote last week to more than a dozen insurers asking them to turn over internal analyses on the law's impact on premiums and costs.

The insurance industry has also been talking publicly about big potential premium increases in lobbying for tweaks to the law.

The individual market includes about 15 million people, and around 18% of the roughly 149 million with employer coverage were at small companies, according to 2011 figures from the Kaiser Family Foundation. The individual market is expected to grow to around 35 million people by 2016 as a result of the law.

In a private presentation to brokers late last month, UnitedHealth Group Inc., UNH +0.33% the nation's largest carrier, said premiums for some consumers buying their own plans could go up as much as 116%, and small-business rates as much as 25% to 50%. The company said the estimates were driven in part by growing medical costs not directly tied to the law. It also cited the law's requirements that health status not affect rates and that plans include certain minimum benefits and limits to out-of-pocket charges, among other things.

Jeff Alter, who leads UnitedHealth's employer and individual insurance business, said the numbers represented a "high-end scenario," not an average. "There are some scenarios in which a member could see as much as a 116% increase or over," he said, though others, such as some older consumers, could see decreases. He said the company dwelled on the possible increases because it was trying to prepare brokers to speak with clients facing big jumps.

Other carriers have also projected steep rate increases during private meetings and conversations with brokers. Brokers say they are being told to prepare the marketplace for small-business and individual rate increases as carriers get ready to file specific rate proposals and plan designs with regulators.

Insurers are "not being shy that premiums are going to increase in 2014," and are urging brokers to "brace our clients," said John Lacy, vice president of group benefits at Bouchard Insurance, a brokerage in Clearwater, Fla. His firm has been hearing from carrier representatives that individual premiums in Florida could go up 35% to 50%, on average, and small-business rates around 30%, though it hopes to find strategies to blunt the impact.

Aetna Inc., AET +0.42% in a presentation last fall to its national broker advisory council, suggested rates on individual plans not being grandfathered under the law could go up 55%, on average, and gave a figure of 29% for small business rates. Both numbers included 10 percentage points tied to medical-cost inflation, not the law. An Aetna spokesman said the numbers are "still generally in line with what we've been estimating," and represented the average impact in a typical state.

An official with Blue Cross & Blue Shield of North Carolina told a gathering of brokers last week that individual premiums could go up by as much as 40% to 50%, according to brokers who were present. A spokeswoman for the insurer said "we don't have final numbers" yet on premiums.

There has long been debate, even among insurance experts, over how the law will affect premiums. Because the effect is likely to vary, different measurements can arrive at different conclusions. The CBO analysis cited by the administration determined that average premiums for consumers who buy their own coverage would be 14% to 20% lower because of the law—if the law didn't change the types of plans they purchased.

But the CBO also suggested the law would lead to consumers buying more expensive plans, largely because it requires coverage to include certain benefits and limit charges such as deductibles. When this effect was taken into account, the average premiums would go up 10% to 13%, the agency said, though subsidies would ease the bite for most people. The agency also said small-business policies were likely to cost within a few percentage points of the amount they would have without the law.

Health and Human Services officials say competition among insurers, as well as provisions to limit their financial risk from attracting high-cost consumers, will exert downward pressure on premiums, and point to the tax subsidies that will limit many consumers' costs.

Subsidies will be available on a sliding scale for people with incomes of up to four times the federal poverty level—currently $45,960 for a single person and $94,200 a year for a family of four. More than half of the 35 million people expected to be in the individual market by 2016 are likely to qualify for credits. People whose incomes are around the poverty level could see almost all of the cost of their insurance subsidized, while people at the upper end will get only a small discount toward their premiums.

  Read More & Comment...

PCORI Responds to Sequestration By Hiring More Bureaucrats

03/21/2013 05:23 PM |

Apparently Joe Selby at PCORI didn't get the memo about sequestration.. PCORI is on a hiring spree so that more people making $100K or more can spend more time holding meetings to figure out what patient-centered health care is and make pronouncements on innovations years after they have been developed. When hiring more executives is a "major milestone" it's a sign of an organization that has no purpose and too much money.. http://campaign.r20.constantcontact.com/render?llr=rapki9kab&v=001T68Z-93cJFbO-58Y2pQUxjS_-h_D7nyXIv6V_zJlw4-vGaiaoMTWvTBI-IcyaJa2IhODCUKV8Qwmuz24-vIo7iXI62DGzN3WRaJLrkLIkKJ4zIKqf8v3bl3b6WPpGusbioA3zFucEWY%3D  Read More & Comment...

Wyden Open Spaces

03/21/2013 08:54 AM |

BioCentury reports that Senator Ron Wyden (D-OR.) sent a letter to NIH requesting a list of medicines that have reached the market as result of NIH research since 1995 -- when the agency removed the reasonable pricing clause from cooperative research and development agreements (CRADAs).

Wyden also asked NIH to convene a panel to reexamine the pricing of medicines and treatments that are developed with public funding.

Assuming (and it is not a big assumption) that Senator Wyden wants to show that it’s public money responsible for new drugs – he needs better staff work.

This question has been asked and answered a number of times from a number of different angles. And, at the end of the day, the answer is that NIH-funded research grants are rarely responsible for pharmaceutical breakthroughs – and are never responsible for the complicated and expensive research behind the development phase of drug programs.

Does Senator Wyden even understand the difference?

As the New York Times reported in January 2011, “The National Institutes of Health has traditionally focused on basic research, such as describing the structure of proteins, leaving industry to create drugs using those compounds.”

A quick look at the grants given out by NIH to investigators in academic research demonstrates that taxpayer money is given to pre-clinical activities. The track record of academics moving something into the clinic is quite poor for a variety of reasons. That's where venture capital, biotech, and pharma come in. Indeed without such investment -- which comes earlier than ever before in the discovery process -- taxpayer support for NIH would not be worth the effort. It's the private investment -- which by the way is now increasingly translational in nature and now involves the development of new drug development tools -- that enhances the NIH investment.

Indeed, without contracts and contracting out in key areas such as genomics, proteomics, high throughput screening, biomarker development, the NIH would not be relevant. It relies upon constant collaboration with the private sector at all levels. In fact, efforts to bar NIH scientists from consulting and working with private companies have lead to a massive exodus of key researchers to for profit companies where there is more freedom and resources.

Wyden also requested information about a CRADA covering research on JAK-3 that he said helped lead to the development of rheumatoid arthritis drug Xeljanz tofacitinib from Pfizer. According to Wyden, "taxpayer-funded research was foundational" to the development of the oral pan-Janus kinase (JAK) inhibitor, though he acknowledged Pfizer funded all drug discovery, preclinical and clinical development expenses.

Um, not so fast. In response, Pfizer said it has invested over $1 billion over the past 20 years for the discovery, development and commercialization of Xeljanz. Pfizer also said the CRADA did not yield any compounds or patentable IP.

Wyden made similar requests in the early 90s seeking to regulate prices on drugs developed with the aid of federal resources.

The definition of insanity, said Professor Einstein, “is doing the same thing over and over again and expecting different results.”

Words to the Wyden.

  Read More & Comment...

The Kids are Uhl Right

03/20/2013 09:12 AM |

CDER Staff:

I am delighted to inform you that, effective today, Kathleen (“Cook”) Uhl, M.D., will serve as acting director of the Office of Generic Drugs (OGD) while we initiate a nationwide search for a permanent director. Dr. Uhl most recently served as the senior advisor to the director for OGD.

Dr. Uhl brings a wealth of regulatory and medical policy, scientific, and management experience to the position. In her fifteen years with FDA, Dr. Uhl has become widely-regarded both inside and outside of the Agency as a compassionate, committed, and dedicated leader. Because of her strong management skills and extensive expertise in clinical pharmacology, I am confident in her abilities to lead OGD during a time of transition as we work to evolve quality throughout the Center and implement the Generic Drug User Fee Amendments of 2012.

Dr. Uhl began her FDA career in 1998 as a medical officer in what is now CDER’s Office of Clinical Pharmacology. She has served in numerous positions at FDA, including five years as the assistant commissioner for Women’s Health and as director of FDA’s Office of Women’s Health (OWH). Among her many accomplishments, she is credited with forging new relationships with other federal agencies and the scientific community by establishing a cross-Agency Women’s Health Advisory Council to more effectively identify, communicate, and act on key women’s health issues in the Agency -- and to more closely align OWH’s scientific program with Agency scientific initiatives.

Dr. Uhl returned to CDER in 2010 to serve as deputy director, Office of Medical Policy (OMP) -- a position she held until January of this year. She provided exemplary leadership to OMP during a time of extraordinary change and growth as OMP underwent a major organizational change by becoming a “Super office” -- an office that houses subordinate offices within its organizational structure. Dr. Uhl played a critical role in facilitating OMP’s significant growth in personnel and expanded scope of operations. Further, she was instrumental in FDA’s negotiations with industry for the authorization of the new Biosimilar User Fee Act of 2012 (BsUFA), which was enacted on July 9, 2012, as part of the Food and Drug Administration Safety and Innovation Act. Additionally, Dr. Uhl has extensive knowledge of current quality and risk management processes, as well as standards relevant to FDA’s laws and regulations.

Dr. Uhl received her medical degree from the Medical College of Pennsylvania and completed residency training in family medicine with subsequent fellowship training in medical research and clinical pharmacology. She has held a variety of leadership positions with the American Society of Clinical Pharmacology and Therapeutics (ASCPT), to include serving on their board of directors and as an associate editor for their journal. Further, in 2008 she received ASCPT’s distinguished service award for her outstanding efforts in advancing clinical pharmacology and therapeutics.

Before joining the Agency, she was a clinical investigator and clinician at Walter Reed Institute of Research and Walter Reed Army Medical Center. She retains faculty appointments as associate professor in family medicine and internal medicine at the Uniformed Services University and is a retired officer of the United States Public Health Service Commissioned Corps.

Please join me in welcoming Dr. Uhl to this position. We are fortunate to have someone with her expertise, experience, and abilities leading OGD at this critical juncture.

Janet Woodcock  Read More & Comment...

New York Times Prescription For Health Care Costs: Stop Innovating

03/20/2013 08:11 AM |

In what either be described as a glass half empty perspective or its usual dim view about the developers of new medical therapies, the New York Times reports that spending on prescription drugs in the US declined in 2012 by about 1 percent to $325.7 billion. The paper of record goes on to state "the first time the research firm IMS Health had recorded a decrease in United States drug sales since the company began tracking such numbers in 1957." The word "but" is the biomarker of a reporter's bias.. And so goes on to complain, "But even as the United States is in the midst of what has been called a 'golden' period in spending on drugs, some are warning that the ever-expanding use of generics has masked a growing problem for the government, insurers and others who pay the bill for prescription drugs: the rising cost of complex specialty medicines that treat cancer, rheumatoid arthritis and other diseases." The Times notes that this "potential for higher spending on drugs comes as the nation is struggling over how to contain the cost of health care, which many experts agree is a major threat to the country's fiscal condition." So the fact that there's been a drop in expenditures on medicine is twisted into a story where a potential increase in spending on drugs will bankrupt America. Except that facts get in the way. In 1960 prescription drugs were about 10 percent of health care spending. Those days people were limited to antibiotics, insulin, tranquilizers, diuretics and some crude chemotherapy drugs for cancer. In 2012 prescription drugs were about 10 percent of health care spending for diabetes, mental illness, heart disease, hypertension, targeted cancer treatments, multiple sclerosis, Parkinson's, HIV, hepatitis C and a growing array of rare diseases. Does no change in what we spend on medications as a share of health care spending sound like a threat to America's fiscal condition? And that's not taking into account the fact that each generation of new drugs not only become less expensive over time (price and generic competition ), make treating illness more affordable and, by increasing life expectancy, adds economic value. When we spend more on new therapies, we live longer, healthier lives. If the NYT mindset -- new therapies are a threat to our economic health that must be contained like a virus-- had prevailed even ten years ago we'd be spending less on medications but probably more on other types of care and living shorter, less productive lives.   Read More & Comment...

Lower Drug Spending: The Hidden Opportunity

03/19/2013 09:42 AM |

To the Editor:

Indeed, the cost of specialty drugs loom large on the horizon as the new driver of pharmaceutical costs (U.S. Drug Costs Dropped in 2012, but Rises Loom, NYT, March 19, 2013), but there are two issues absent from this article – and often from the larger debate, that are worth mentioning.

The first is that drug costs represent only 11.5% of our national healthcare expense (only 8.5% for on-patent “name brands.”) The second is that, as we make continued strides towards more and more accurate companion diagnostics, we will be able to grab the brass ring of the “four rights” (the right medicine in the right dose to the right patient at the right time). This is the real definition of “personalized medicine” and the ensuing reduction in therapeutic guesswork will save lives and the enormous expense of failing our way to clinical success.

  Read More & Comment...

The other Mass

03/19/2013 08:51 AM |

BioCentury reports that in a speech to the Massachusetts Biotechnology Council on Friday, FDA Commissioner Margaret Hamburg provided an update on the status of two of the agency's regulatory initiatives -- the breakthrough drug and biosimilars pathways. Hamburg said the agency has received a total of 31 breakthrough therapy designation requests, nine of which have been granted and 10 denied. One request was withdrawn, and 11 are pending.

Breakthrough drug designation, which was created by the FDA Safety and Innovation Act, commits FDA to collaborate with a sponsor to enable expedited development and review of compounds for serious or life-threatening diseases that show substantial improvements over existing treatments in early trials. Hamburg said FDA is developing guidance to describe and explain the criteria for its expedited development and review programs, including breakthrough designation.

Additionally, Hamburg said the agency has not received any applications for a biosimilar or interchangeable biologic under the 351(k) pathway, which was signed into law in 2010 as part of the Affordable Care Act. As of March 14, Hamburg said the agency had received 51 requests for meetings for 12 different reference products, with 38 initial meetings held with potential sponsors. She said FDA has received 15 INDs for biosimilar development programs.

  Read More & Comment...

Odds and Ends

03/18/2013 08:49 AM |

US Supreme Court is slated to hear oral arguments involving a case in which a patient sued the manufacturer of a generic version of the nonsteroidal anti-inflammatory drug, Clinoril (sulindac), alleging use of the NSAID caused her to become physically disfigured, disabled and almost completely bind. The blog said tomorrow's case could "likely settle lingering questions about a small but high-impact class of lawsuits against generics." Meanwhile, Democratic lawmakers "are at odds" with the Department of Justice, which is "siding with drug makers, arguing that the courts shouldn't be able to second-guess" the FDA's "approval decisions." In contrast, Rep. Henry Waxman (D-CA), who "wrote almost all" of the nation's generic drug laws, and Sen. Tom Harkin (D-IA) "disagree. ... Congress never intended for FDA approval to preempt lawsuits over drug safety, Waxman said in a court brief."

  Read More & Comment...

Office Politics

03/18/2013 07:42 AM |

I believe you have my stapler.

So, what of the OPDP reorg?

The article below (from FDA Week) does a good job with the particulars. Let me add to (and slightly better position) my quotes therein.

One way to look at the problem is that OPDP is under-resourced in terms of dollars, staff – and staff expertise.  True.

Another way to look at it is that the form and function of this Office needs to be reexamined. Also true.

And the answer isn’t user fees.

Sources Mixed On Impact Of FDA Drug Advertising Office Reorganization

The new structure of FDA's drug advertising compliance office -- a switch that divides up oversight by therapeutic area rather than by type of advertising -- could have mixed results, sources said following the agency's March 8 announcement of the reorganization. The more generalized approach could lead to less predictability for industry, but the change could also help focus reviewers, leading to greater efficiency and a more critical view of the data, sources said, noting the impact on enforcement actions is unclear.

Agency drug center chief Janet Woodcock said the changes will allow OPDP to more effectively review direct-to-consumer and health professional advertising by increasing efficiency, improving work distribution and eliminating redundancy, while also emphasizing the agency's commitment to providing close oversight of DTC advertising. The move comes as FDA vows to continue its tough scrutiny of off-label drug promotion despite a recent court decision that some have said could stem such oversight.

FDA announced March 8 that it is restructuring its two divisions overseeing consumer and professional drug advertising, and realigning them among various therapeutic divisions overseeing the two promotion categories.

Under the new structure, the new Division of Advertising and Promotion Review I will include four teams that will oversee consumer and professional advertising related to neurology and psychiatry; hematology; oncology; and analgesics, anesthetics and antivirals. Four teams in the new Division of Advertising and Promotion Review II will review promotion for osteoporosis, reproductive and urology; dental, dermatology, and metabolic and endocrine; allergy, gastroenterology, pulmonary and rheumatology; and anti-infective, cardiovascular, medical imaging, ophthalmology, renal and transplant.

Some sources contend the move is little more than "rearranging the furniture." Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner for external relations at FDA, said the move shows OPDP is understaffed, adding that the move spreads existing resources too thin.

"It is simply taking an under-resourced office and relocating its existing expertise," he said.

Pitts said the move could have a downside as reviewers will need to become more generalized to oversee both consumer and professional advertising. A more generalized approach could mean less predictability, he said.

"What it will do is it will further decrease the predictability and advice that office offers," Pitts said. "That is certainly not a step in the right direction."

Arnie Friede, an attorney with his own practice, said in theory, the reorganization will allow reviewers to become experts on the science related to a certain class of drugs and reduce duplication, allowing more efficient reviews over time. He added that expertise could allow reviewers to view the data with a more critical eye. A better understanding of a class of drugs could make reviewers more sensitive to analysis that industry has done or it could lead them to be more skeptical, Friede said.

"I think that time will tell whether the rationale for the changes will accomplish those things," he said. "The rationale seems, in theory, reasonable. Whether that translates into more enforcement or less enforcement over time, that is hard to know."

The latest reorganization comes after FDA, in 2011, renamed and elevated OPDP within a new super office, creating separate divisions to examine consumer drug promotion and professional drug promotion. The most recent change was prompted by a review of the workload and review processes in OPDP's two divisions to improve their overall impact and effectiveness, according to Woodcock.

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Penny-wise. Euro-Foolish.

03/15/2013 06:51 AM |

One thing is evident, Europeans ought to learn more about the free market pricing of generics in the US – tenders, discounting and reference pricing don’t work.  One can make the argument that same applies in the branded pharmaceutical marketplace.
 
A review of generic medicine pricing in Europe

Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(1):8-12.

“The penetration of generic medicines is more successful in countries that permit free pricing of medicines than in those that have price regulation. Although tendering systems may reduce (generic) medicine prices in the short term, little is known about the overall long-term impact of such systems.”

The rest of the story can be found here.

Also, see here for a related story in the Pink Sheet.

Michael Moore, are you listening?  Read More & Comment...

Geba Gone

03/14/2013 07:22 AM |

Changes in CDER's Office of Generic Drugs

CDER Staff:

I would like to make you aware of a change in the Office of Generic Drugs’ (OGD) leadership.

Dr. Greg Geba, OGD director, has informed me that he will resign from his position on March 15. With the pending realignment of OGD’s CMC functions into the new Office of Pharmaceutical Quality (OPQ), which Dr. Geba fully supports as part of the quality evolution in CDER, he nonetheless saw this movement as creating challenges for implementing his original and full vision for OGD’s remit. Additionally, it put into new perspective considerations for him relocating his family to the Washington, D.C. area.

Dr. Geba came to CDER during a busy time and has led OGD’s work to improve efficiencies in the generic drug review process — significantly reducing the backlog of pending ANDAs, preparing for the hiring of new staff, and successfully guiding OGD in implementing the Generic Drug User Fee Act (GDUFA), as well as overseeing OGD-related organizational changes to stand up the new OPQ.

Please join me in thanking Dr. Geba for his significant contributions and wishing him well.

In the interim, I will serve as the acting OGD director while we initiate a nationwide search for our next OGD director.

Janet Woodcock
  Read More & Comment...