From T-Bills to T-Cells

10/02/2009 09:45 PM |

BioCentury reports that late Thursday ...

The Senate Finance Committee night passed an amendment to healthcare reform legislation that would create a $1 billion temporary tax credit over two years for investments in drug R&D by companies with 250 or fewer employees.

The measure, sponsored by Sen. Robert Menendez (D-N.J.) and backed by the Biotechnology Industry Organization (BIO), would cover expenditures made in 2009 and 2010. Companies that don't have a tax liability would have the option to receive the credit in the form of a grant.

In allocating the credits and grants, the amendment instructs the U.S. Treasury to consider only projects that: "show reasonable potential" to "result in new therapies to treat areas of unmet medical need or to prevent, detect, or treat chronic or acute disease and conditions;" or to "reduce long-term health costs in the United States; or to "significantly advance the goal of curing cancer within a 30-year period."

In addition, the Treasury would consider which projects have the greatest potential to create and sustain high quality, high-paying jobs in the U.S. and to advance U.S. biomedical competitiveness.

Projects that received a credit or grant would not qualify for existing R&D or Orphan tax credits, or for bonus depreciation.

The legislation still is subject to modification as it moves through Congress. The Finance Committee is expected to approve America's Healthy Future Act early next week. It will then be merged with legislation passed by the Health, Education, Labor and Pensions (HELP) Committee and sent to the full Senate for a vote. The final Senate bill would have to be reconciled with healthcare reform legislation coming out of the House.
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Does bioequivalence = therapeutic equivalence?

10/02/2009 12:22 PM |

Dr. Temple challenged companies to undertake a trial using patients who say that they stopped getting symptom relief after they were moved to a generic version of their drug in order to determine whether there are actual differences in the concentrations of the drugs over time in a subgroup of patients. Yet, he said no one has shown interest in running such a study.
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How much variation does current bioequivalence standard really allow?

10/01/2009 06:42 PM |

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AAPS Meeting in Baltimore: Insomnia Pills?

10/01/2009 04:25 PM |

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Feeling Well on Generics?

10/01/2009 02:59 PM |

Whether Wellbutrin and its generic actually are bioequivalent or not is not something that I can adjudicate this afternoon. But the AAP S meeting presentations have certainly highlighted that it is a controversy that remains undecided. And perhaps most worryingly, it is but one case that highlights the FDA’s unwillingness to engage with indications of lack of bioequivalence.
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AAPS Meeting in Baltimore: The Dangers of Dose Dumping

10/01/2009 01:49 PM |

Well, the actual title of the conference is "Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products".   But the core issue of the conference is whether the generic version of  extended release drugs -- used widely to treat pain, mental illness, Parkinson's, and bacterial infections -- deliver the medicine to the right place at the right time in the right amount.  Too much can be painful, even deadly.  Too little can cause setbacks.  The drug might be cheaper but the outcome is costly. 

To date no one has kept track of the total impact on patients. In part that's because until 2007 generic companies were not require by the FDA to monitor the effect of their products in the marketplace and only then it was limited to opioid based painkillers.  The increased use of generic lamotrigine is strongly associated with increased physician visits and hospitalizations. The same goes for switching patients to a generic version of other anti-convulsants, anti-depressants, etc.  

The key question of the conference is what can companies do to assure that all medicines affect us in more or less the same way.  As I have written before, one step in the right direction is to hold drugs that are supposed to have the same benefit and same risks to the same standards of post market evaluation.  Another approach, to be discussed by Gerard Sanderink of Sanofi will be how to use biomarkers to more precisely predict dose response and absorption of products in the earliest stages of development and periodically in the post market.  

The conference may seem mundane.  However the fact that Bob Temple is showing up indicates just how serious the FDA is about this issue.  And more generally, it underscores the fact that the public at large is unaware of the importance of how a drug is delivered.   Discovering a medicine is half the battle.  Making sure it is delivered safely and effectively is as important. 

Accordingly,  CMPI will be covering the AAPS conference "live" with bloggers and a video crew in a effort to "deliver" the modified release message in a way that it interesting and timely. 


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Punting along the REMS

09/30/2009 10:51 AM |

The long-awaited and much anticipated draft guidance on REMS can be found here.

Also now available (and worth a careful read or two) is the FDA's strategic plan for risk communications.  Here's the press release, along with a link to the complete document.

FDA NEWS RELEASE

For Immediate Release: Sept.30, 2009

Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Issues Strategic Plan for Risk Communication
Establishes framework for communicating with public about FDA-regulated products

The U.S. Food and Drug Administration today issued its Strategic Plan for Risk Communication, which outlines the agency’s efforts to disseminate more meaningful public health information.  The plan also lays out a framework for the FDA to provide information about FDA-regulated products to health care professionals, patients and consumers in the form they need it and when they need it, and for how the agency oversees industry communications.

“We are committed to improving communications the public receives about the products we regulate,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA must communicate frequently and clearly about risks and benefits and inform patients and consumers about ways to minimize risk as they become increasingly involved in managing their health and well-being.”

The plan defines three key areas–FDA’s science base, its operational capacity and its policy and processes – in which strategic actions can help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies over 70 specific actions for the FDA to take over the next five years, including 14 that the agency commits to accomplishing over the next year. They include:

• Designing a series of surveys to assess the public’s understanding of, and satisfaction with, FDA communications about medical products
• Producing a research agenda for public dissemination
• Creating and maintaining a useful, easily accessible internal database of FDA and other relevant risk communication research
• Developing an expert model to characterize tobacco-use related consumer decision-making and better understand the likely impact of FDA oversight of tobacco products
• Developing a “library” of multi-media communications on safe food practices for general education purposes and for use with crisis communications concerning food contamination episodes
• Posting pictures of FDA- regulated products affected by Class I or high-priority Class II recalls as part of recall notices/information
• Developing detailed action plans at the agency and center levels for implementing and achieving the proposed action steps, including timelines, responsibilities and resource needs

The plan reflects the FDA’s belief that risk communications must be adapted to the needs of different audiences and should be evaluated to ensure effectiveness. The plan also focuses on improving two-way communication through enhanced partnerships with government and non-government organizations, and focuses on policies that affect areas of high public health impact.

For more information:
FDA’s Strategic Plan for Risk Communication

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Cadillac Mission Creep

09/30/2009 10:18 AM |

Speaking of taxing “Cadillac” health plans, today’s New York Times reports that:

“The leading proposal in the Finance Committee would apply to family insurance plans that cost roughly $21,000 and up starting in 2013. For the sake of fairness, the threshold would vary based on geography and the average age of a company’s work force. In all, something like 10 percent of plans would be subject to the tax in 2013, according to the Center on Budget and Policy Priorities, a research group."

(The complete New York Times story can be found here.)

60% of the American public gets their health benefits through their jobs -- and they’re not “free.” According to the Kaiser Family Foundation, the average American worker with “employer-provided” healthcare pays about 41% of the cost.

So – will benefits be taxed before or after the 41%? Clearly the answer is – before.

And as everyone’s favorite economist, Robert Reich, opines, "According to the Congressional Budget Office, taxing all employee health benefits would yield a whopping $246 billion every year. Even limiting the tax to higher-income employees would go a long way to funding universal health care. Employer-provided health insurance is the biggest tax break in the whole federal income tax system.”

The AFL-CIO’s Gerald Shea, the union’s top healthcare lobbyist, sees the definition of “Cadillac” shifting with time, “People are going to see this as a huge middle-class tax hit.”

The New York Times agrees:

“ … the number of affected plans would grow over time. The Senate has been talking about having the threshold rise each year by the inflation rate plus one percentage point. Since medical spending has been rising much faster than inflation, more and more plans would probably cross the threshold in the years after 2013. Over the next decade, the Congressional Budget Office has estimated that the tax would pay as much as 25 percent of the cost of extending coverage to the uninsured.”

And so does Robert Reich. “So a sensible and politically feasible alternative is to limit tax-free employer-provided health benefits to workers whose incomes are under, say, $100,000 a year, and subject those with higher incomes to progressively higher taxes on them."

Can you say, “mission creep?”
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NY Times Gives Birth to Tort Bar Flack

09/30/2009 12:47 AM |

Reading Natasha Singer's article about the "safety" of Yaz and Yasmin -- two popular oral contraceptives I felt, as Yogi Berra would say, like it was deja vu all over again.   Where or where did Ms. Singer find her muse about the risks of birth control, I wondered? 

"...recently, the Yaz line’s image has been clouded by concerns from some researchers, health advocates and plaintiffs’ lawyers. They say that the drugs put women at higher risk for blood clots, strokes and other health problems than some other birth control pills do. Those critics, though, are up against a large European health study, sponsored by Bayer, the German pharmaceutical giant, that reported the opposite conclusion. The Bayer-financed study said that cardiovascular risks in women taking Bayer products were comparable to those taking an older formula of birth control pills."

www.nytimes.com/2009/09/26/health/26contracept.html

Hmm...

Here's a blog from a law firm leading the litigation against Bayer, the company that makes Yaz:

"The risks associated with this popular birth control pill are severe; many women who took Yaz or Yasmin have died or been seriously injured because of the serious health risks associated with the drug.  In fact, the FDA received over fifty reports of Yaz and Yasmin-related deaths between 2004 and 2008, most involving increased levels of potassium and occurring in women as young as 17 years old.  Imagine how many went unreported!  A growing number of lawsuits have been filed by or on behalf of these women, charging the drug manufacturer with inadequately warning them of the increased risks Yaz and Yasmin pose to those women who use the oral contraceptive.

While the public-at-large and many physicians may not recognize an adverse reaction to drospirenone, the health risks have been known for longer than many realize.  In 2002, the British Medical Journal reported some practitioners’ concern about the drug as a result of 40 cases of venous thrombosis among women taking it.  Also, in 2003, the Journal published a paper that detailed reports of thromboembolism deaths and injuries thought to be caused by Yaz and Yasmin.

www.nolan-law.com/yasmin-yaz-ocella-birth-control-injuries/#side%20effects

The FDA has been reprimanding Yaz and Yasmin manufacturers for misleading and inadequate television advertising for the drug for quite some time."

Here's Singer again... stoking the fires, fanning the flames, leading the witness...

"The health questions and the lawsuits may rattle consumer confidence, but the warnings from federal health authorities about advertising and quality control raise larger questions about Bayer’s approach to complying with government rules, said Michael A. Santoro, an associate professor at the Rutgers Business School who has studied ethics in the pharmaceutical industry. "


False Claims Act anyone?  That's the fulcrum  which the trial lawyers use to leverage meager findings about safety into a conspiracy of silence and misrepresentation.  

I see another Avandia in the making.  

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FOBS and Strange Bedfellows

09/29/2009 10:06 AM |

Via the Pink Sheet:

The potential for physicians to favor innovator biologics over follow-on biologics because of a reimbursement advantage would be eliminated under an amendment to health care reform legislation adopted by the Senate Finance Committee Sept. 23.

The amendment, offered by Sen. Charles Schumer, D-N.Y., says the goal is "to ensure that patients and the Medicare program utilize biosimilars appropriately" and "create parity between brand name biologics and biosimilars and save patients and Medicare money."

The basic problem the amendment is trying to solve is the fact that, under current law, each biological product must have a separate billing code for reimbursement by Medicare Part B. Since the reimbursement rate under Part B is the average sales price of the drug plus six percent, if a biosimilar were introduced at a lower price than the innovator, there would be no incentive for physicians to use the lower-priced drug, since the six percent administration payment would be higher for the innovator. As a result, there would be no downward pressure on prices.

To eliminate this disparity, the amendment would provide equal administration fees for both the innovator, or reference product, and the follow-on biologic. The description of the amendment says a biosimilar approved by FDA and assigned a separate billing code would be "reimbursed at the ASP of the biosimilar plus six percent of the ASP of the reference product."

Brand Pharma May Dodge A CBO Bullet

The committee adopted the amendment by unanimous voice vote, and brand pharma stalwarts Sens. Orrin Hatch, R-Utah, and Michael Enzi, R-Wyo., joined as co-sponsors.

Brands may be supportive of the idea of reimbursement parity for physicians because, if treated as the fix Medicare needs to accommodate FOBs, it would mean that brands avoided potentially much more consequential modifications to the program.

The Congressional Budget Office has previously suggested that there would be additional savings from follow-on biologics if they are put on equal footing with innovators in government health care programs, not just in terms of physician reimbursement, but product coding as well, which would mean that brands would be reimbursed at the FOB price.

In a December 2008 score of legislation options, CBO said that putting a biosimilar in the same reimbursement code as its brand-name counterpart would save the government $10.6 billion over 10 years, about 30 percent more than the $8.1 billion it would save if they were not in the same code.

Many observers believe that such a coding change would need to be made by statute, and that without it Medicare would never fully embrace FOBs. Indeed, while the Schumer amendment removes a disincentive to prescribing FOBs, it does not seem to create an incentive for their use either.

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The Road Not Taken

09/28/2009 12:52 PM |

“There is a choice to be made. One road leads to greater individual rights, freedom, productivity, good doctor-patient relations, further advances in health care, and better lives. The other leads to statism, government control of the individual, falling levels of productivity, a lack of innovation in medicine, drone-like doctors and nurses, and ultimately, more death.”

For the sake of future Americans, let us hope and pray that we take the first road.
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Maher mars health care debate

09/28/2009 12:37 PM |

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Chucking Generics?

09/25/2009 08:12 AM |

Senator Schumer during Finance Committee mark up:

"People have unique needs. I take Lipitor, they put me on the generic, Zocor, my cholesterol went up.  They put me back on Lipitor, my cholesterol went down."

You mean that all statins aren't the same?  That different people respond to different drugs in different ways. That generic substitution can have ... unintended consequences? Holy cow! And who is the mysterious "they" the Senator refers to?  Probably not his Uncle Sam.

(PS, "Zocor" is not the "generic."  Simvastatin is the generic.  Not the same thing.  But that's another story for another time.)
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I'm OK, You're 510(k)

09/24/2009 01:44 PM |

And at the top of the list should be the growing and worrisome EU/US medtech gap.

FDA NEWS RELEASE

For Immediate Release: Sept. 23, 2009

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA: Institute of Medicine to Study Premarket Clearance Process for Medical Devices

The U.S. Food and Drug Administration today announced that it has commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States.

The IOM study will examine the premarket notification program, also called the 510(k) process, for medical devices. While the IOM study is underway, the FDA’s Center for Devices and Radiological Health (CDRH) will convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process.

“Good government conducts periodic reviews and evaluations of its programs,” said Jeffrey Shuren, M.D., acting director of CDRH. “Our working group and the IOM’s independent evaluation will help us determine how the 510(k) process can be improved to better support FDA’s mission to protect and promote the public health.”

The 510(k) process was established under the Medical Device Amendments of 1976 with two goals:

* Make safe and effective devices available to consumers
* Promote innovation in the medical device industry.

During the past three decades, technology and the medical device industry have changed dramatically, making it an appropriate time for CDRH to review the adequacy of the premarket notification program in meeting these two goals.

Established by the National Academy of Sciences, the IOM provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.

As part of the study, the IOM will convene a committee to answer two principal questions:

* Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
* If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?

The $1.3 million IOM review is slated for completion in 2011, and is one of six priorities Dr. Shuren has outlined for CDRH. Others include:

* Creating an internal task force on the use of science in regulatory decision-making
* Developing an effective compliance strategy
* Optimally integrating premarket and postmarket information
* Increasing transparency in decision-making
* Establishing clear procedures to resolve differences of opinion.

The IOM will hold two public workshops during the next nine months as part of its review, and will publish a final report in March 2011 containing its conclusions and recommendations.

The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk and generally require premarket approval to support their safety and effectiveness before they may be marketed. Class III devices include heart valves and intraocular lenses.

Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices can be marketed after submission of premarket notifications—also called 510(k) applications—that support their substantial equivalence to legally marketed devices that do not require premarket approval.

Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and require premarket approval.

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Some Tough Questions Surrounding Social Media

09/24/2009 12:20 AM |

From The Voice of San Diego:

My Grandmother Out-Tweets Your Biotech
By DAVID WASHBURN

Wednesday, Sept. 23, 2009 | Very few industries are as willing to take risks on new technologies as the biotech industry. Companies will spend millions, and even billions, developing a drug that has a chance to cure a cancer or a device that could change the face of heart surgery.

Yet when it comes to social media, the industry has proven to be risk adverse. In fact, your grandmother is probably more likely to be active on Twitter or Facebook these days than a pharmaceutical, medical device or contract research company.

"What we've got is the social media Maginot Line," said Peter Pitts, director of global health care for the public relations firm Porter Novelli, referring to the French army's strategy of fortifying its borders during World War II.

"If they avoid social media they are safe. But what is happening is that important discussions about the medications and how they affect patients are happening minus the participation of companies," Pitts said after a panel discussion hosted Wednesday by Biocom, the local biotech industry association.

The FDA has scheduled a two-day public meeting in November to solicit views regarding how it should deal with social media. Among other things, the agency wants to discuss how companies will fulfill their fair balance obligations in social media, how they will deal with inaccurate information posted about their products as well as adverse event reporting.

The meeting, Pitts said, is an acknowledgement by FDA officials that the agency is "behind the curve," and needs to address the issue. FDA officials involved in the planning of the meeting could not be reached for comment today.

Pitts and others hope a larger embrace of social media emerges from the FDA meetings, and that the industry realizes that it is "irresponsible not to use social media." They raised the issue of benefits that a drug may have that are not officially recognized by the FDA.

Say, for example, that a clinical trial shows that a drug has an effectiveness against a certain type of cancer tumor that was not thought possible when the drug was submitted for FDA approval, and therefore isn't on the FDA label for the drug.

"If they choose not to share that information in the best way possible -- which is social media -- is that the ethical and moral thing to do?" Pitts said.

An even more vexing issue facing both the companies and the regulators is how they deal with adverse event reporting. Suppose, Pitts said, that someone taking a cancer drug develops numbness in their fingers, and then writes about it in a blog or on a Facebook wall.

"This is an opportunity in real time to understand adverse reporting issues," Pitts said.

"Rather than avoid it from a legal and regulatory standpoint, they should pursue it from a public health perspective. That, however, is a very contentious proposition."

The complete story can be found here.

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Newt Nails It On Healthcare Reform

09/22/2009 08:36 PM |

On Fox News Newt explains why Congress refuses to make the same 365 choices available to members of Congress as part of health care reform:  "Because it doesn't increase the control government has over health care." 

Which is also one reason why insurance under the health care proposals are 3 times more expensive than are available in the marketplace.

The other reason:  legislation is nothing but a huge subsidy to large corporations, most union benefits and the liberal imagination.  Heaven forbid, people choose health plans with higher deductibles, lower premiums, less coverage than the micromanagers want us to have. 

On a related note: Here's President Obama's OMB director on what is really happening to health care costs:

"On the consumer side, and despite media portrayals to the contrary, the share of health care expenditures paid out of pocket, which is the relevant factor for evaluating the degree to which consumers are faced with cost sharing, has plummeted over the past few decades, from about 33% in 1975 to 15% today. All available evidence suggests that lower cost sharing increases health care spending overall. The result is that collectively we all pay a higher burden, although the evidence is somewhat mixed on the precise magnitude of the effect."

Rather than allowing people to choose plans that allow for cost sharing and accumulate cash (especially important for people who are chronically ill) and include health insurance premiums to lock in rates and pay for one time costs Orszag endorses the current solution: using an expert panel to determine what doctors should do and how much they should get paid for it:

"The real traction, though, will come from building the results of that research into financial incentives for providers. In other words, if we move from a “fee-for-service” to a “fee-for-value” system, where higher-value care is awarded with stronger financial incentives and low- or negative-value health care is penalized with smaller incentives or perhaps even penalties, the effects would be maximized."

All of which is at the heart of the Baucus bill and every other piece of legislation.   Well since CER has been implemented elsewhere and costs have gone up, what has been the result on patients?  Dr. Orszag let's it slip:


"... if all one did was, say, reduce payment rates under Medicare and Medicaid, and then tried to perpetuate that over time without a slowing of overall health care cost growth, the result would probably be that fewer doctors would accept Medicare and Medicaid patients, creating an access problem that would be inconsistent with the underlying premise and public understanding of these programs."

www.issues.org/24.3/orszag.html

Which brings us back to Newt.  All of this happens because of government control.  The unintended consequences of government run health care.
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FDA's Hamburg: Critical Path Not Chopped Liver

09/22/2009 08:22 PM |

If you have not heard or read FDA commissioner's speech on regulatory science -- namely the Critical Path to promote personalized medicine in product review and post market management --  you should.  It lays out vibrant vision of how the FDA can continue to adapt to and encourage companies to adopt genomics, biomarkers and other 21st century tools to make products safer and more effective. 

We may disagree with the Obama vision of health care but we also share his commissoner's vision of how to sustain medical innovation. 

Watch Commissioner Hamburg's remarks here.


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Importation Redux

09/22/2009 08:29 AM |

It's back.

According to Senate leadership aides, Senate Majority Leader Reid may bring a bill to the Senate floor in the next two weeks that would allow the importation of prescription drugs from Canada.

Wonder if Senator Reid has discussed this act of pharmaceutical imperialism with our neighbors to the North. Last conversation I had with Canadian officials left no doubt they are very concerned with how such an action would impact their domestic medicines supply.

And is this bill about drugs from Canada or drugs through Canada?

Here we go again.

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Milking Industry

09/21/2009 03:32 PM |

AdvaMed’s Stephen J. Ubl, on Chairman Max’s Mark:

“Exempting Class I devices does not address the arbitrary nature of this tax. It will still cover scores of consumer products and medical devices used by millions of Americans every day. For instance, contact lenses and solution and battery powered breast pumps for nursing mothers will still be taxed.”

And, in a further feat of legislative legerdemain, maxi pads are not taxed, while scented maxi pads are.
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DDMAC goes for 2(.0)

09/21/2009 11:32 AM |

Time to get out and dust off your Part 15 mojo for the November 12-13 "Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools" meeting.

It's about time.

According to the announcement:

"... FDA recognizes that the Internet possesses certain unique technological features and that some online tools that may be used for promotion offer novel presentation and content features. Another emerging issue involves the reporting of adverse event data because such information may initially be revealed using social media platforms in the context of Internet promotion for FDA-regulated medical products."

The complete announcement can be found here.

Groovy baby.

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