Safety, Security & Supply

12/27/2010 09:09 AM |

A Double Edged Sword for U.S. Healthcare

By Paul Howard

  Read More & Comment...

Tevi’s words of wisdom

12/23/2010 04:27 PM |

  Read More & Comment...

Pharmville

12/23/2010 09:07 AM |

Drug Industry Dismayed by FDA Delay on Digital Marketing Guidelines

Three-Month Pushback Frustrates Industry Digging into Social Media and Internet Advertising

By Rich Thomaselli

NEW YORK (AdAge.com) -- The Food and Drug Administration just dropped a lump of coal in the pharmaceutical industry's stocking. The FDA has delayed its much-anticipated regulatory guidance for digital pharma marketing until the first quarter of 2011, further frustrating an industry eager to broaden its scope of internet and social-media marketing.

The agency released a statement Tuesday night to the EyeonFDA blog that read: "The Division of Drug Marketing, Advertising and Communications (DDMAC) has been researching draft-guidance topics on the following issues related to internet/social-media promotion of FDA-regulated medical products: Responding to unsolicited requests; fulfilling regulatory requirements when using tools associated with space limitations; fulfilling post-marketing submission requirements; online communications for which manufacturers, packers or distributors are accountable; use of links on the internet; correcting misinformation."

It continued: "Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements."

The FDA was expected to announce online guidelines by the end of this year after holding two-day public hearings in November of 2009. Delaying that potentially for three more months -- and guaranteeing draft guidance on only one of those topics -- is not sitting well. "It's infuriating," said one health-care-centric ad agency president. "On one hand, you want FDA to get it right. On the other hand, the (public hearings) were last November. They've had more than a year to get it right. It's bullshit."

But Paul Machado, CEO and founder of New Jersey-based Health Innovation Partners, said the delay is not such a bad thing. "If you think about it from the FDA's perspective and the challenges they're dealing with regarding health-care reform, why come out with a position? There's not a need right now. Why bother?"

Mr. Machado added that the industry will "continue to meander through the forest and see what happens, be conservative, see what others do and slowly create a position for themselves. Even if they do come out with guidance, it will take companies a long time to react to it. The reality is, you can only do so much anyway. "

At the November 2009 hearings, more than 60 people spoke, including representatives from Google, drug-makers and ad agencies. A month later the FDA published its Guidance Agenda for 2010, and the "Guidance on the Internet and Social Media" was listed -- meaning, at some point this year, the FDA expected to issue those guidelines.

One of the first inklings that it was going to be delayed came earlier this month when the FDA issued its Guidance Agenda for 2011 and "Guidance on the Internet and Social Media" was again listed.

Asked in an email why the agency would delay its online guidance, former FDA associate commissioner Peter Pitts replied: "Lack of knowledge. Lack of urgency. First Amendment angst."

Ironically, as the pharmaceutical industry itself begs for online/social-media guidance in order to pursue marketing in the new media, the first documented enforcement letter stemming from the FDA's new "Bad Ad" program was online-related.

The Dec. 3 letter from the Division of Drug Marketing, Advertising and Communications (DDMAC) to Hill Dermaceuticals claimed the company's web pages for its Derma-Smoothe product "are false or misleading because they omit and minimize the risks associated with the use of Derma-Smoothe Body Oil, overstate its efficacy, present unsubstantiated superiority claims, broaden and inadequately communicate the indication, and present unsubstantiated claims for the drug product. Thus, the webpages misbrand the drug in violation of the Federal Food, Drug and Cosmetic Act."

The "Bad Ad Program," instituted in May, urges the medical community to report ads and sales pitches that violate FDA rules. Ostensibly, the program was designed primarily to catch what the FDA can't see -- the behind-office-doors pitches from pharmaceutical sales reps to physicians. But the broad definition of the program allows doctors and medical professionals to report false or misleading ads to the FDA, and to do so anonymously.  Read More & Comment...

Wednesday reading

12/22/2010 11:18 AM |

  Read More & Comment...

From the Day Late/Dollar Short Dep't

12/22/2010 09:15 AM |

Rep. John Dingell (D-Mich.) and three co-sponsors introduced the Drug Safety Enhancement Act (H.R. 6543), which seeks to enhance FDA's authority to regulate drug safety. The bill would create a registry of domestic and foreign drug facilities; generate funding for increased GMP inspections; provide FDA with mandatory drug recall authority and increased civil and criminal penalties; and require identification numbers for drug establishments and importers. The bill was co-sponsored by Rep. Henry Waxman (D- Calif.), Rep. Frank Pallone (D- N.J.) and Rep. Bart Stupak (D- Mich.).
  Read More & Comment...

Seeking (social media) Guidance

12/21/2010 03:35 PM |

The FDA will not be issuing a guidance on social media any time soon on any of the following:

• Responding to unsolicited requests
• Fulfilling regulatory requirements when using tools associated with space limitations
• Fulfilling post-marketing submission requirements
• On-line communications for which manufacturers, packers, or distributors are accountable
• Use of links on the Internet
• Correcting misinformation

The FDA goes on to say:

Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.

My colleague Peter Pitts has written smartly on the subject of social media. If you read between the lines of the non-issuance,  Peter's prior observation that there is a lot that the FDA will and cannot regulate suggests that any guidance will be a non-event.

Beside,  as I point out in my book tabloidmedicine,  most of what defines the risk and benefits of a medicine on line is a result of what others are saying or spreading in ways that will always be unregulated by the FDA.   So what's a company to do? 

1.Fill the void with tools that give consumers information and the ability to determine in partnership with their physicians what's best. 
2. Ask people to volunteer participating in certain social networks,  only ask and enter when invited. 
3.  Respond quickly and proactively to scaremongering,  counterfeiting scams and hype. 

If companies wait for the FDA to define the online environment it will already be too late. Guidance should come from within (and not just from the legal department!).
  Read More & Comment...

Patients are a virtue

12/21/2010 09:12 AM |

Here’s a significant potential PDUFA addition – adding patient perspectives to the FDA’s analyses of drug application reviews.

 

In the minutes of the 11/22 PDUFA negotiating session, the FDA said that information about patients’ understanding of existing treatment tools is considered valuable, but is not consistently available during the review process.

This new initiative would place in front of frontline reviewers the views of patients who, for example, are willing to live with more serious side effects or safety concerns because they have failed on previous treatments and have no other options.

 

The agency said it wants to host meetings with review divisions and relevant patient advocacy groups to talk about available treatment options and unmet needs. That information would be used to help draft guidances for specific indications.

 

This is a real advance and will significantly enhance the role of the FDA’s Office of Special Health Issues. Bravo.

 

And speaking of greater input, industry is keen to bring more clarity and transparency to the approval process. Specifically, industry officials want a more structured risk-benefit formula included in PDUFA V and asked that the agency begin using it in its decision-making (similar efforts under way at the EMA).

 

CDER Director Janet Woodcock, “We’re all for that and we’ve been working on that, the industry’s been working on that, other academic parties have been working on that. So I think we will come up with something there.”

 

Office of New Drugs Director John Jenkins has said on more than one occasion that the framework should be simple and support sound expert judgment, not replace it.

 

According to Jenkins, such a model could improve predictability and consistency, support more structured discussions and provide concise descriptions of evidence and the risk-benefit implications.

 

Amen.

It's time to see all these good words turned into legislative deeds.  And the sooner the better.

  Read More & Comment...

PDUFA Agonistes

12/20/2010 09:32 AM |

A few thoughts on PDUFA V before we settle in for the holiday break.

Two Teams.  As negotiations proceed, it becomes increasingly obvious there’s an emerging duality – the FDA’s Part B “asks” and industry’s legitimate worries over what was promised, but not delivered, from PDUFA IV.

Perhaps both agency and industry should create two teams so that both sets of issues can be addressed in a timely and comprehensive manner.  Special teams, as they say, win ballgames.

Carrots and Sticks. Everyone wants to be rewarded for promises delivered – but perhaps its time for some hurt to be written into the system for promises unfulfilled.  PDUFA is a partnership and partnerships are built on mutual respect and understanding.  When one side rewrites the rules while the game is in play, that’s not partnership – it’s a thorny thicket of unintended consequences. Not to put too fine a point on it, but predictable timing for first cycle decisions count.

When the agency can “stop the clock,” PDUFA dates lose all meaning.  It’s the same argument used in Inherit the Wind to dispute the length of Earth’s “first day.” After all, since the Sun hadn’t been created yet, the first day could have been 24 hours or 24 billion years long. Sometimes a review feels just like that.

And finally …

First Principles.  It’s time to remember why PDUFA exists in the first place. And that reason is predictability. PDUFA V will either provide more predictability or more excuses.  The latter is not an acceptable choice for industry – nor will it be tolerated by the 112th Congress.

For all concerned – and particularly for patients – PDUFA V needs more resonant cowbell.

  Read More & Comment...

Back from Israel

12/19/2010 12:19 PM |

I arrived days after horrible fires in the Carmel forest and in the thick of two days of the worst wind storm in the history of the Jewish state.  Power was lost and quickly restored with typical Israeli aplomb and matter of factness.   Then (when I wasn't shopping with my son Zach) I participated in the Fourth Annual Health Care Technological Innovation program for Israeli life science entrepreneurs along with CMPI board members Gad Berdugo and Steve Sammut and former FDA official, all around great guy Dan Schultz and this year's CMPI Odyssey Award winner, Frank Douglas. The takeaway from the meeting: precompetitive collaboration, personalized medicine and the enduring value of innovation, even in the face of a complex FDA regulatory environment.  Frank and I went to the National Institute for Biotechnology of the Negev for a two hour presentation that demonstrated again Israel's astonishing contribution to personalized and predictive medicine.  From Tel Aviv and back I learned more about commercialization and innovation from Frank Douglas than I had in the past decade. 

I was also pleased to have my book Tabloid Medicine launched and want to thank Peter, Dr. Weber, Mario and Ben for their support!  Here's my observation on the new google.com 3-D body browser

www.technewsworld.com/story/Google-Really-Gets-Under-Peoples-Skin-71487.html

tabloidmedicine.com
  Read More & Comment...

Make Mine a Cuba Libre

12/18/2010 11:46 AM |

Proving once again that Moore is Less.

WikiLeaks: Cuba banned Sicko for depicting 'mythical' healthcare system
 
Authorities feared footage of gleaming hospital in Michael Moore's Oscar-nominated film would provoke a popular backlash
 
By Amelia Hill
guardian.co.uk, Friday 17 December 2010
 
A WikiLeaks cable reveals that when Michael Moore's film was shown to Cuban doctors, they were 'disturbed at the blatant misrepresentation of healthcare in Cuba'.
 
Cuba banned Michael Moore's 2007 documentary, Sicko, because it painted such a "mythically" favourable picture of Cuba's healthcare system that the authorities feared it could lead to a "popular backlash", according to US diplomats in Havana.
 
The revelation, contained in a confidential US embassy cable released by WikiLeaks , is surprising, given that the film attempted to discredit the US healthcare system by highlighting what it claimed was the excellence of the Cuban system.
 
But the memo reveals that when the film was shown to a group of Cuban doctors, some became so "disturbed at the blatant misrepresentation of healthcare in Cuba that they left the room".
 
Castro's government apparently went on to ban the film because, the leaked cable claims, it "knows the film is a myth and does not want to risk a popular backlash by showing to Cubans facilities that are clearly not available to the vast majority of them."
 
Sicko investigated healthcare in the US by comparing the for-profit, non-universal US system with the non-profit universal health care systems of other countries, including Cuba, France and the UK.

It was nominated for an Oscar for best documentary feature but was also castigated for being naive and tendentious.

The cable comes from the United States Interests Section in Havana (USINT) – staffed by US foreign service personnel and local staff employed by the department of state, the unit is formally a section of the Embassy of Switzerland, although it operates independently of the Swiss in virtually all but protocol respects.

The secret 2008 cable is based on reports from the USINT's foreign service health practitioner (FSHP) of her conversations with local people, unauthorised visits to Cuban hospitals, and experience of helping USINT American and Cuban personnel access healthcare.

The cable describes a visit made by the FSHP to the Hermanos Ameijeiras hospital in October 2007. Built in 1982, the newly renovated hospital was used in Michael Moore's film as evidence of the high-quality of healthcare available to all Cubans.
 
But according to the FSHP, the only way a Cuban can get access to the hospital is through a bribe or contacts inside the hospital administration. "Cubans are reportedly very resentful that the best hospital in Havana is 'off-limits' to them," the memo reveals.

According to the FSHP, a more "accurate" view of the healthcare experience of Cubans can be seen at the Calixto Garcia Hospital. "FSHP believes that if Michael Moore really wanted the 'same care as local Cubans', this is where he should have gone," the cable states.
 
A 2007 visit by the FSHP to this "dilapidated" hospital, built in the 1800s, was "reminiscent of a scene from some of the poorest countries in the world," the cable adds.
 
The memo points out that even the Cuban ruling elite leave Cuba when they need medical care. Fidel Castro, for example, brought in a Spanish doctor during his health crisis in 2006. The vice-minister of health, Abelardo Ramirez, went to France for gastric cancer surgery. The neurosurgeon whoheads CIMEQ [Centro de Investigaciones Médico-Quirúrgicas] hospital – widely regarded as one of the best in Cuba – came to England for eye surgery, returning periodically for checkups.
 
"After living in Cuba for two and a half years, treating numerous Cuban employees at USINT, and interacting with many other Cubans, the FSHP believes … preventive medicine in Cuba is a by-gone ideal, rather than the standard practice of care," the memo concludes.
 
* On his website today Michael Moore has said that Cuba did not ban his documentary, Sicko
 
  Read More & Comment...

A Healthcare Carol

12/17/2010 01:51 PM |

Some thoughts from the Ghost of Healthcares Yet to Come.

What business are you in?  To most people, including most of your industry colleagues, you are in the business of selling.  To survive and thrive you must be in the business of advancing the public health.  And to do that you must be seen as both teacher and expert.

And partner.

Partner with physicians, certainly.  With patients, definitely.  But also with government.  You must walk the tenuous tight rope of being both regulated entity and public health colleague with the regulatory mandarins who watch over you.

Your internal legal and regulatory departments will gasp.  But you will gain.  And it can (indeed must!) be done.

As ever greater regulatory oversight for your marketing practices comes into play across the globe, you must rethink both the type and timeframe for successful communications.  Rather than focusing strictly on short-term product sales programs, you must now create a firm foundation for trust built on the substrate of public health progams.

Consider the FDA’s “Safe Use” initiative.  In addition to adverse event reporting, the FDA wants to communicate with physicians and patients about how drugs and devices can be used safely, appropriately.  Because a product used safely is a safer product.  But the FDA needs allies.  It has no budget for public health outreach beyond the bully pulpit.  Who will step up to the plate to work with the agency?  What are the perceived barriers that you face in doing so?  If you want the agency to be both regulator and colleague, so too must you be prepared to play those identical roles.  It takes two to tango.

Similarly in the EU, the rules are changing when it comes to the Brussels concept of Information to Patients (ITP).  Consider this verbiage from a recent report from the EU Parliament:

“Member States authorities may not be in a position to fully address patients’ needs in terms of the substance of information and the access via different means … The pharmaceutical industry has the potential to be an important source of information to respond to the growing demand for more and better information by patients and to help reduce the current information gap, provided that there will be adequate rules to ensure reliability, objectivity, and quality of information.”

We are running out of failed 20^th century marketing alternatives.  It’s time to embrace public health communication programs as a powerful tool for corporate reputation, payer relations, physician education, patient empowerment, and yes – product sales.

But this strategy also requires a new appreciation of time.  No longer can you only design programs for short-term unit sales purposes.  That only reinforces your perception as greedy marketer.  The 21^st century demands a new paradigm.  It won’t be easy.  And it can’t be achieved through lip service.  You can’t talk yourself out of something you acted your way into.

The roadside of healthcare sales strategy is strewn with the carcasses of failed marketing alternatives.  Advancing the public health in concert with the governments with whom you do business is not only the right thing to do – it’s the smart thing as well.

  Read More & Comment...

A metastatic decision

12/17/2010 08:47 AM |

I do not believe that the FDA took cost into consideration in its decision to remove Avastin’s breast cancer indication.  Nevertheless, the unintended consequences are going to be deadly.

Medical decisions need to be left to patients and their doctors. They're the ones with access to crucial information needed to make the right decision about treatment options. Conceiving of medicine as one-size-fits-all is dangerous and ignores the individual biological nuances inherent in the U.S. patient population.

Of course, doctors could still provide Avastin for breast cancer treatment by prescribing it "off label." But an FDA denial means that public insurance programs like Medicaid and Medicare could refuse pay for the drug. Private plans would almost certainly follow suit.

In fact, evidence suggests that insurance companies are rooting for the FDA to de-list Avastin for advanced breast cancer. Already, the Regence Group, a regional health insurer in the Pacific Northwest, has published a policy listing Avastin for breast cancer as "medically unnecessary." And this policy was applied retroactively!

Without insurance coverage, patients would have to bear the full brunt of Avastin's price tag, which typically runs about $8,000 a month. Technically, women would still have access to this life-saving medication. But the only ones who will actually get to use it are the very slim minority with great financial means.

Worse still, revoking Avastin's approval would stifle medical innovation. Virtually every oncologist believes that the future of cancer treatment lies in complex, biologic drugs like Avastin. These kinds of drugs differ from traditional treatments in that they can be hypercustomized to meet the specific medical needs of individual patients. They also tend to be more effective.

By revoking Avastin's approval, the FDA would effectively eradicate the financial incentive for drug companies to develop advanced treatments like it. We'd lose out on an entire generation of cures.

  Read More & Comment...

Hoosier Daddy

12/17/2010 08:39 AM |

Eli Lilly & Co. President and CEO John Lechleiter was the sole representative of the biopharmaceutical industry at President Obama's Wednesday meeting with business leaders on how to encourage U.S. job growth and economic recovery.

During the meeting, Lechleiter discussed the "life sciences innovation hub" that has grown up in Lilly's home state of Indiana as a potential model for promoting innovation across the country, according to a company statement.

Let’s pick up on that theme and strive to make the 2011 health care discussion all about innovation – because that’s what it really is all about.  Read More & Comment...

Surprise!

12/16/2010 07:52 AM |

At Tuesday’s White House confab on intellectual property, Homeland Security Secretary Janet Napolitano declared that eliminating counterfeit pharmaceuticals has become a top priority for federal customs agents and prosecutors, and they expect it to remain high on their agenda next year.

This came as a surprise to many (including many at the FDA).

Nevertheless – good and important news.

  Read More & Comment...

Speed Kills

12/16/2010 07:45 AM |

According to Russell Wesdyk, scientific coordinator in the FDA's Office of Pharmaceutical Science, generic drug manufacturers would face fewer factory inspections and save as much as a year developing products in exchange for paying fees for the first time under a Food and Drug Administration proposal.

Terrifi.  The more expeditiously generic drugs can move through the FDA process the better … but not at the expense of safety.

Wesdyk shared that the FDA may waive "preapproval inspections" done after companies submit generic-drug applications. Instead, it would rely on periodic inspections that focus on firms' broader manufacturing practices.

Really?  Fewer inspections?  Isn’t that going against the prevailing philosophy that FDA needs to undertake more and more rigorous inspections and particularly overseas (where many generic products are manufactured)?

Speed is important.  Safety is more important.  To achieve both requires the agency to have more inspectors – and that means more money for the FDA.

Safe generics brought to market more swiftly?  Show me the money.

  Read More & Comment...

Universal coverage…with a little help from the U.S.

12/15/2010 06:14 PM |

  Read More & Comment...

The Other East Coast

12/15/2010 07:23 AM |

From the pages of the Wall Street Journal:

BEIJING—Big drug makers from the West are making a new kind of push into fast-growing Asian markets: creating drugs for diseases that are more prevalent there.

Within the past year, Pfizer Inc., the world's largest drug company by sales, began work in China on an anti-inflammatory compound to treat liver disease, a big killer in Asia. Health-products giant Johnson & Johnson announced last month a collaboration with a university in Beijing to research infectious diseases threatening the region. Bristol-Myers Squibb Co. also last month announced a partnership with Nanjing-based Simcere Pharmaceutical Group to develop a cancer treatment.

The approach marks a shift from the industry's history of designing medicines for patients in the West. While multinational drug makers might study experimental medicines in Asian subjects, the companies would use the clinical-trial results to gain regulatory approval in the U.S. and Europe.

Western drug makers often bypassed medical conditions specific to Asia. Liver disease, certain cancers and some infectious diseases are more prevalent in countries like China and Thailand because of differences in the environment, genetic factors and some behaviors.

Firms are now pouring into Asian markets with the goal that growth there will help them cope with pricing pressures and aging products in the U.S. and Europe. Sizable and increasing numbers of Asians can afford to buy Western drugs. About $40 billion of prescription drugs are sold in China, for instance, and the market is growing about 25% a year, according to David Maris, an analyst at CLSA, an Asia-focused investment group headquartered in Hong Kong. The pharmaceutical market in the U.S. and Europe is growing 2% to 5% a year.

Given the market's size, more pharmaceutical executives are starting to see the region's specific medical needs as potential sources of profit. U.S. and European drug makers have invested more than a billion dollars over the past year into building research-and-development and manufacturing capabilities in the area, according to CLSA.

And more investment is on the way. In announcing job cuts last month, Bayer AG said it wanted to use the savings for the "expansion of capacities in Asia," including the addition of 2,500 jobs in emerging markets.

Pfizer opened a research facility in Shanghai five years ago and established a network of doctors and academics to give input on the clinical needs of patients there. The New York company saw an opportunity in an anti-inflammatory compound that showed promise for treating liver disease. The disease can follow infection with the hepatitis B virus, which is much more common in Asia than in the West. Some 70% to 90% of people in China and some other Asian countries are infected with hepatitis B by the age of 40, compared to fewer than 20% in North America and Western Europe, according to the World Health Organization.

Johnson & Johnson's collaboration with Tsinghua University—one of the top universities in Beijing whose tree-lined campus is filled with gleaming research centers and surrounded by Chinese offices of U.S. technology giants Google and Microsoft—illustrates a partnership approach to drug R&D. The goal of the project's early-stage laboratory work is to better understand diseases like hepatitis B, tuberculosis and bird flu, paving the way for new therapies.

Since 2008, J&J has been involved in another partnership with Tianjin Medical University to improve treatment of head, neck and other cancers prevalent in Asia.

Tianjin Medical University, about 80 miles southeast of Beijing, has about 2,000 inpatient cancer beds. It is collecting tumor tissues and blood cells from each patient.

By collaborating with the university, J&J hopes to more quickly identify distinctive biomarkers, such as genes or proteins, that might signal which drugs would work best for what cancer patients, said William Hait, J&J's head of oncology.

J&J helped train local researchers on how to do detailed genetic and molecular work because they "didn't have critical mass of people with these capabilities," said Dr. Hait. The training has taken longer than expected, but the research projects are up and running, he said.

Bristol-Myers is taking yet a different approach—by licensing to a Chinese firm the development of a compound that shows promise for treating gastric, esophageal and lung cancers.

The New York drug maker sold the compound's Chinese development and marketing rights after deciding a local company could do the work more efficiently. Under the terms, Simcere will run and fund the research through mid-stage human development.

Though this might mean giving up the short-term benefit of selling any resulting products in China, Bristol-Myers can draw long-term lessons from the experience, said Jeremy Levin, who oversees transactions at Bristol-Myers. "We're learning from others in other countries," he said.

All of the drugs targeting diseases prevalent in Asia remain years off. Yet, their development can pay immediate dividends by generating goodwill with Asian patients and governments impressed by the focus on local medical needs, said Sati Sian, general manager in China of IMS Health, a drug industry consultancy.

Companies may face some skepticism from patients, however.

Mr. Chi, a 48-year-old Beijing resident who asked to be identified only by his family name, said it is a positive that Western drug companies are trying to make more new medicines but he doesn't like their focus on treating diseases more common in Asian populations with the intention of selling them first to people in China. "I would wonder why you [the company] don't start giving it to people in your country first," said Mr. Chi, a building manager.

Mr. Chi, who was waiting to see a doctor Monday because he was suffering from an upset stomach, generally prefers traditional Chinese medicines for "regulating" bodily processes, like problems with sleeping, because they are made of natural ingredients and have fewer side effects than Western medicines.

Write to Shirley S. Wang at shirley.wang@wsj.com and Jonathan D. Rockoff at jonathan.rockoff@wsj.com

  Read More & Comment...

Yes Virginia, there is an interstate commerce clause

12/14/2010 06:58 AM |

Yes Virginia, there is an interstate commerce clause.  And there may yet be coal in your stocking.

As you no doubt know already, Judge Hudson found that Congress could not order individuals to buy health insurance.

In a 42-page opinion, Hudson said the provision of the law that requires most individuals to get insurance or pay a fine by 2014 is an unprecedented expansion of federal power that cannot be supported by Congress's power to regulate interstate trade.

"Neither the Supreme Court nor any federal circuit court of appeals has extended Commerce Clause powers to compel an individual to involuntarily enter the stream of commerce by purchasing a commodity in the private market," he wrote. "In doing so, enactment of the [individual mandate] exceeds the Commerce Clause powers vested in Congress under Article I [of the Constitution.]

This will largely be reported on and discussed relative to its impact on the continued viability of the Patient Affordability Act (aka “health care reform” aka “ObamaCare) – and that’s an important conversation for the 112^th Congress and others to have.  But there’s a more urgent public health imperative: uninsured, healthy young adults. 

Not that the legislation, as passed, would have accomplished anything significant about driving young, healthy people into the insurance pool.  The anemic penalties actually disincentivize youthful participation.  After all, why not pay a monthly penalty (less than even a very affordable monthly insurance premium) if, when you do face a medical emergency, you can’t be turned down or charged more?

Judge Hudson didn’t use this in any way relative to his ruling – but his ruling does give us another bite at the “young, health and uninsured” apple.

And bite we must.

If we cannot bring healthy young adults (and, for that matter, healthy adults writ large) into the insurance pool, coverage costs will increase -- and fast.  As more people with pre-existing conditions are brought into the insurance system (via state insurance exchanges, vouchers, etc.), costs will skyrocket.  The curve will be bent alright – in the wrong direction.

Thanks to Judge Hudson we have a chance to revisit a better way to address this situation – insurance regulatory reform.

A study by University of Minnesota economists Stephen Parente and Roer Feldman shows that Congress could boost by more than 12 million the number of people who have health insurance without spending taxpayer dollars. The change required is to allow people to buy health insurance across state lines, so they can shop for less expensive policies. For example, a typical health-insurance policy in heavily regulated New York costs more than three times as much as in less regulated Iowa ($388 a month versus $98 a month for the same coverage).

The penalty “stick” (whether you like it or not) will not even be an option if Judge Hudson’s ruling stands.  So we’d better start looking for some carrots – and lower cost policies is a particularly juicy one.  But that must also be paired with a strong public awareness campaign.  As any expert in behavior modification will tell you, the best way to get people to do something you want them to do is to make them understand why it is in their best interest to do so.

And the sooner the better.

  Read More & Comment...

Me and Sally in the Health Policy Alley

12/13/2010 08:37 AM |

Here are three segments from Sunday's "BioCentury this Week" --

Sally Greenberg (National Consumer's League) and I discuss health care and the 112th Congress:

Part 1

Part 2
  Read More & Comment...

Mulling it over

12/13/2010 08:14 AM |

From the Pink Sheet:

FDA Floats 15-Month Review Timeline For PDUFA V; Firms Mull Tradeoff On Speed Vs. Certainty

Fifteen months could become the expected review time for new molecular entity and novel biologics license applications, based on a proposed new review model. FDA and industry are considering a review timeline that would automatically add two months to all NME new drug applications and novel BLA application goals with the potential for an additional three-month extension under certain conditions. The new model only would apply to those applications, according to minutes of a Nov. 18 Prescription Drug User Fee Act reauthorization negotiating session with industry. All other NDAs and BLAs would be reviewed under the existing application review system, where the standard review time is 10 months. FDA and industry would receive some of their primary requests under this proposal. It would allow more time to complete reviews in the first cycle and also add a late-cycle meeting between sponsors and the agency to discuss major issues. The new model also would address an industry request for more certainty in the review process. While the existing stated goal is 10 months for all standard applications, FDA’s record of meeting that timeframe is inconsistent. If both sides can agree to the additional review time for NME NDAs and original BLAs, which theoretically require more work, industry could gain the additional consistency in review times that it wants. That is, of course, if the agency actually can finish the reviews within the longer timeframe. The review clock would begin two months later than usual – at the conclusion of application filing and validation activities – to create time for the late-cycle meeting, according to the minutes. The delay would allow the agency to throw out most of the automatic extensions it had been pushing for in previous meetings. Extensions for advisory committees, foreign facility inspections and Risk Evaluation and Mitigation Strategies would not be necessary, the agency said in the minutes. However, the mandatory three-month extension for a major application amendment, no matter when it was submitted, still would be possible. FDA had argued it could not meet the prescribed review goals because applications with a major amendment – as well as those requiring a REMS, foreign inspection and advisory committee meeting – required too much additional work.  The agency also said a REMS submission could be considered a major amendment. FDA said applications submitted with a REMS would not trigger an automatic extension, but the agency could take the major-amendment extension if the REMS had to be revised during the review, according to the minutes. The additional two months for all NME NDAs and novel BLAs would push the standard review goal to one year. A major amendment or REMS issue would extend it to 15 months. Interestingly, FDA is asking for more review time as it is near meeting performance goals under the existing PDUFA standards. In fiscal year 2008, the agency reviewed 87% of all standard NMEs and novel BLAs within 10 months, just short of its 90% goal. FDA has more work to do finishing non-novel application reviews on time. Its performance for non-NME or novel BLA applications was 85% in FY08. The new review time of 15 months would still be below the recorded median review time for standard applications, which was 16.2 months in fiscal year 2008. That was the highest since the 20-month median recorded in 2001. The new model also would address only a fraction of all the NDA and BLA applications FDA receives. NMEs accounted for about 22% of all original NDA and BLA applications received from fiscal years 2005 through 2009, according to the FY 2009 PDUFA Performance Report, released in October. In FY 2009, 31 NME applications were received, the most in the five-year span. However, the total of original applications, 147, also was the highest during the period, the agency said in the report. Later Meeting Includes More FDA Officials Under the new model, a late-phase meeting after primary and secondary reviews are finished would be allowed to conduct discussions of application problems as well as advisory committee and risk management plans. It also could cover new data or analysis submissions and whether FDA would review them during the first cycle, according to the minutes. The meeting would include signatory authorities (those who make the final decisions on applications), an industry request during previous meetings. The agency also is willing to give its advisory committee meeting background package to the sponsor 21 business days prior to the scheduled meeting under the new model. Industry had asked in previous meetings to see the documents earlier. If applicable, the late-phase meeting would be scheduled between the receipt of the background package by the sponsor and the AC meeting. The new review timeline would include an additional mid-cycle communication previously offered, where a project manager would give application status updates and talk about any major deficiencies that had been found. The agency previously had offered the mid-cycle meeting, but it was too early for sponsors’ needs. Applications Need More Information Additional expectations also would be placed on industry in the new model. Applications would be expected to be complete at the time of submission and include a complete list of manufacturing facilities so the agency could better plan and conduct pre-approval inspections before advisory committee meetings. Both sides also considered including a complete list of clinical investigation sites in the application so the agency could more easily verify data integrity and protect human subjects, according to the minutes. FDA said comprehensive pre-submission meetings about potential safety issues could help identify risk management needs earlier. Industry representatives said they were looking at best practices for those meetings. More Discussions Of New Model Ahead There was no indication in the minutes that industry had accepted or rejected the new model. Industry representatives appear to have spent much of the hour-long session listening. The new model is the latest move in a long journey toward an upgraded application review system. FDA had argued for more time, while industry wanted additional meetings for sponsors. In an attempt to make more time during the review process for mid-cycle meetings, the agency had at one point proposed a four-phase process that would have allowed FDA to stop the review clock in order to conduct the mid-cycle meeting with the sponsor. That proposal solicited too many questions from both sides and was dropped. The agency then returned to its automatic extensions proposal, which came earlier in the negotiating process. More discussion of the late-phase meeting proposal is scheduled for a future session. If a process resembling the 15-month timetable is enshrined in PDUFA V, however, it may confirm to many in industry that their relationship with the user program is indeed a loveless marriage, in that they are paying more for slower.

  Read More & Comment...