FDA's Public Citizen

10/17/2009 07:58 PM |

First the good news:

John M. Taylor, III will occupy a new position at FDA, Counselor to the Commissioner, where he will oversee the agency's crisis response functions as well as advise on a range of policy and regulatory matters.  An attorney, Mr. Taylor served previously with FDA as a staff lawyer, an advisor to previous Commissioners, and as Associate Commissioner for Regulatory Affairs.  He most recently has been Executive Vice President, Health, at the Biotechnology Industry Organization, after serving as a Divisional Vice President for Federal Governmental Affairs at Abbott Laboratories.

I served with John and he is a stand-up guy.  Great hire.

Now the other news:

Peter G. Lurie, MD, MPH, will serve in the agency's Office of Policy, where he will help develop strategies to facilitate medical product availability to meet critical public health needs, reporting to the Assistant Commissioner for Policy.  Dr. Lurie has most recently been Deputy Director of Public Citizen's Health Research Group in Washington, DC and is an adjunct faculty member at Johns Hopkins Bloomberg School of Public Health and the George Washington University School of Public Health and Life Sciences.   

I’ve debated Peter.  Smart guy.  Highly political guy.  Public Citizen’s well-known position on “medical product availability” is that most products are “too dangerous.”  What’s next?  Sid Wolfe as FDA’s Philosopher-in-Residence?

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One Witt. Two Errors.

10/16/2009 10:22 AM |

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Witt Picking

10/16/2009 09:52 AM |

Ann Witt, health counsel extraordinaire to Representative Henry Waxman(and who previously served as acting director of DDMAC and advisor to the Commissioner), is returning to the FDA to serve in the agency’s Office of Policy, Planning and Budget.  

Does this mean Ms. Witt will fill Jeff Shuren’s shoes?  (Jeff is currently serving as the Acting Director at CDRH.) That would give Ann the platform to address some of her favorite issues such as off-label communications, advisory committee operations, and the medical device review process.  It’s also interesting to note that Ms. Witt was a key player in Dr. Kessler’s (failed) attempt to claim regulatory authority over tobacco.

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Doctor, Lawyer and (Acting) Indian Chief

10/15/2009 09:04 AM |

FDA Principal Deputy Commissioner Josh Sharfstein graced the luncheon dais on the final day (Wednesday) of AdvaMed’s third annual shindig.

Following a video welcome from his boss, FDA Commissioner Peggy Hamburg (who advised the audience they weren’t obligated to laugh at any of Josh’s jokes), Dr. Sharfstein spoke about the five issues driving reform over at CDRH.  They are:

(1) The development of predictable pathways. Good to hear that the corner office understands that predictability is an important public health issue.

(2) 510(k) reform (and the IOM study of same). Josh noted that “not everyone” was unhappy with the status quo. 

(3) Development of a comprehensive compliance strategy.  Urgent since the absence of such a program dilutes credibility for both regulator and regulated.

(4) A total lifecycle approach to post-market safety.  A la REMS – this (at least in theory) gives the agency greater comfort to approve riskier products.

(5) Better communication of why (and how) CDRH reaches its decisions.  This jives with the agency’s broader transparency initiative (which is being coordinated by Sharfstein).

Josh lauded Acting CDRH Director Jeff Shuren, noting that he (Jeff) wasn’t just keeping the seat warm until a permanent director can be appointed, but had the full faith and authority of the Commissioner to drive the above five-pointed program forward.

Jeff Shuren is a serious guy and whip-smart.  An MD and a JD – he now completes the triad as (acting) indian chief.

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Clinical Trials and Tribulations

10/14/2009 09:51 AM |

The European Commission is inviting feedback from stakeholders on how the Clinical Trials Directive (Directive 2001/20/EC) might be improved.

The commission wants to know whether the scope of such community-wide authorization procedures should be optional, with the choice being left to the sponsor. Also, it asks whether such procedures should cover all clinical trials preformed in the EU or whether they should be limited to only some clinical trials (for example multinational trials).

Stakeholders are asked to submit feedback on which option is preferable and on the practical and legal issues that would have to be considered if they were to be adopted.

While ethical issues clearly fall within the remit of member states and would remain there, the commission has several suggestions to ensure better co-operation and exchange among national ethics committees to improve the ethical review of clinical trials.

The consultation document contains several examples of inconsistencies in the current application of the directive in member states.

For example, there are different interpretations of what could be considered a substantial amendment; this has resulted in a situation whereby the company regards something as a substantial change more often than it actually should in order to avoid problems of non-compliance.

Also, problems relating to the reporting of suspected unexpected serious adverse reactions (SUSARs) have led to multiple reporting of the same SUSAR, lack of reporting and unreliability of community data on SUSARs. Moreover, the number of SUSARs received differs disproportionately among some member states.

The consultation document builds on the findings and recommendations of an EU-funded study – the Impact on Clinical Research of European Legislation (ICREL) – that was issued earlier this year. The ICREL project was initiated in January 2008 and it measured the impact of the directive on four key stakeholder groups – commercial and non-commercial clinical trials sponsors, competent authorities and ethics committees – between 2004 and 2007.

All fine and good and important and timely – but what about enhanced harmonization with, among others, the United States?  First things first perhaps, but the transatlantic issue must be addressed – and sooner rather than later.

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Snowe Job

10/13/2009 06:40 PM |

 
The Senate Finance Committee puts a happy face on a horrible health care reform bill that will have to be dumped into the HELP Bill...And Olympia Snowe goes along.to help the process along...  Here are the talking points since no one will read the bill (amended by me)

 

Eight Things to Know about the America’s Healthy Future Act (Amended for honesty and accuracy)

1. Individuals and employers who are satisfied with their current health insurance coverage can keep it and would not be required to change health plans.  (For five years.  And then individuals and employers -note, not employees-  would be forced to buy health plans through exchanges that cost up to three times as much as their previous coverage with benefits they may not want or use.  Poor and working class people will have no choice but Medicaid, which will double in size even as physician  pay is cut.  Good luck trying to keep your own doctor in either case unless you pay cash.) 

2. No American can be denied health insurance or charged more because of a pre-existing health condition.  (But since Americans who are and stay healthy will subsidize those of us who get sick and enroll only when they are seriously ill, the costs of coverage will increase or care will be rationed.   Probably both.  And Americans with pre-existing conditions will be denied coverage of drugs or  tests and be forced to wait to see specialists as health plans, under the threat of a public option trigger, will cut access to care that the Obama administration regards as unnecessary/)

3. Health insurance companies will not be able to discriminate on the basis of gender or health status -- so insurance companies can’t charge more for women or Americans who are sick.

(See above. This is pay for performance in perverse. ) 

 

4. Health insurance companies will no longer receive tax deductions if they give their executives excessive salaries and compensation.  (And this improves health care access and quality how?)

5. Members of Congress will be required to buy their health insurance through the same exchanges that people in their own states will use, instead of having a separate Congressional health plan.  (Yes, but Members of Congress will have their insurance deeply subsidized.)

6. Health insurance companies will no longer be able to limit how much coverage you can use over your lifetime or how many benefits you can use each year.  (Sounds good.  But remember the government will be making those decisions from here on in.   What benefits you use and how much will be decided by a Quality Czar who will issue reimbursement and coverage decisions for health exchanges based on what bureaucrats believe is cost effective.  That’s rationing.)

7. The bill specifically says there will be no Medicare benefit cuts for individuals. In fact, it strengthens Medicare’s finances so the program can continue to provide benefits for years to come.  (Nice try.  The bill specifically cuts Medicare Advantage, the fastest growing program for the most chronically ill seniors.   Score a big one for AARP which , in exchange for shilling for Obamacare, will reap billions as seniors dumped from Advantage have to buy supplemental coverage for what the shuttered program used to pay for.   It specifically reduces what doctors will get under Medicare.  It specifically seeks to reduce how much doctors do based not on how sick people are (see the similar contradiction in point 6) but on the lowest amount of care given per person regardless of burden of disease.  And it micromanages the decision of whether to pay for new technologies to assure that fewer people get innovations more slowly.     Maybe it’s not a cut, but it is denial of care.

8. Low-and middle-income seniors will get 50 percent of their drug costs paid for when they reach the so-called doughnut hole in the Medicare Part D prescription drug program, where no coverage is provided today.  (And what drugs they get will be determined by a government panel that will increasingly delay access to new drugs based on price alone and without regard to individual differences. )

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Atonal Melody

10/12/2009 08:48 AM |

Remember Melody Peterson?  She used to cover the pharmaceutical beat for the New York Times until she was, well – until she didn’t any more.  Now her occasional column inches appear where they belong – on pages designated "opinion." On Saturday (10/10/09) she had an op-ed in the Los Angeles Times. The title of her piece, “Healthcare reform without drug price controls? That's sick.”

Ms. Peterson needs some fact checkers.  Some examples:

“Over the last 30 years, the industry hasn't focused its efforts on discovering those truly amazing innovations that can change the practice of medicine.”

Really?  Cardiologists, oncologists, psychiatrists, endocrinologists, and just about every other specialist – as well as internists would likely disagree – and strongly. Thirty years ago was 1979. Does Ms. Peterson need a list of 30 years worth of pharmaceutical innovation? Looks like it.

She continues:

“When Congress expanded Medicare in 2003 to cover the cost of prescriptions, the industry's lobbyists got language into the bill that made it illegal for the government to negotiate prices and act like a savvy medicine shopper.”

Melody refers to the Non-Interference Clause -- but gets her facts wrong.  That particular codicil was initially drafted not by “industry lobbyists” during the Bush Administration, but during the Clinton years by then Senators Tom Daschle and Ted Kennedy.  Pesky facts!

Relative to government-dictated pharmaceutical price controls, Ms. Peterson writes that, “… studies have shown it would save billions of dollars a year.” She then forgets to cite any studies.

Well, consider this statement from Stanford Business School's Alain Enthoven and Kyna Fong, “Neither economic theory nor historical experience suggests government price negotiation will achieve lower drug prices.”

And this, according to that mouthpiece of the right-wing conspiracy, USA Today -- "Both the non-partisan Congressional Budget Office and Medicare actuaries have said they doubt the government could negotiate lower costs than the private sector.”

Facts?  They just get in the way when the end justifies the means. 

Melody writes,

“Nearly one of every five dollars that we spend each year goes to the drug companies, doctors, hospitals and the rest of the medical system.”

Yes – but how is this money spent? Well, since her essay is about on-patent pharmaceuticals, it would have been useful (one would think obvious and necessary) to offer a breakdown.  Here’s what she omitted – our national percent spend for on-patent medicines is about 8% of the total. Less than a dime on the dollar.

Towards the end of her, um, opinion piece, Peterson writes, “Congress must pass legislation to ensure that every American has access to medical care. And study after study has shown we can do that without breaking the bank -- if only we reform the system to hold down costs. But the drug companies, which are spending more on lobbying than any other industry, are determined to make sure that doesn't happen.”

So many studies!  Not one listed.  And – last I looked -- the pharmaceutical industry is spending tens of millions of dollars in advertising in support of healthcare reform.

“Facts do not cease to exist because they are ignored.”

-- Aldous Huxley

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Veritas? No Mas!

10/09/2009 09:07 AM |

Whenever my father said something my grandfather didn’t agree with, zayde would shrug and say, “For that you went to Harvard College?”

Yesterday I debated a professor from Harvard College -- John Abramson, MD, professor of clinical medicine and author of "Overdosed America." The venue was Minnesota Public Radio. We debated the issue, “Is Drug Research Biased.” 

Dr. Abramson was, to be polite, ill-informed.  He did, however, come clean and admit he is an occasional witness-for-hire for trial lawyers. Oddly, he kept making peculiar comparisons between comparative effectiveness and ... climate change.  Afterwards, when I visited his web site (www.overdosedamerica.com) it was … all about climate change. 

For this he teaches at Harvard College?

Have a listen and judge for yourself.  The radio program can be found here.

Comic relief?  Not quite ... but almost.  How sad.

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Doctors Don't Count

10/08/2009 08:37 AM |

When it comes to healthcare reform, doctors don’t count … when it comes to cost analysis that is.

The Senate Finance approach to healthcare includes upwards of $245 billion to adjust Medicare payments for physicians. But -- for reasons that defy logic – that number is excluded from the Congressional Budget Office’s scoring.  It’s the same political legerdemain that refuses to call a tax a tax.

The so-called “doc fix” would ensure that physician pay isn't cut. Some say the payment is a political carrot designed to ensure doctors' support of health care overhaul. Maybe so, but it is real money and should be included in the CBO scoring of any healthcare reform bill.

Honestly – a healthcare bill that doesn’t include Medicare payments to physicians?

As my kids would say, "word."

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Of "Interest"

10/07/2009 08:56 AM |

Last week I sat on the final panel of the Fourth National FDA Regulatory Symposium.  The topic for discussion was “Striking the Right Balance:  How to Manage Conflicts of Interest in the Wake of the IOM Report and Congressional Reform Proposals. 

Moderated by Wayne Pines (APCO), my fellow panelists were Eric Campbell (Associate Professor Harvard University) and Marc Wilenzick (Assistant General Counsel, Pfizer – and a former Assistant Chief Counsel at the FDA).

Some commentary:

• We should all pay attention to our nomenclature.  It’s not about “conflict of interest” – it’s about (as Secretary Sebelius correctly says) “interest.”  And having an “interest” is not necessarily a bad thing – as long as you’re transparent about it.

• Dr. Campbell, who sat on the IOM’s COI committee, said that the Institute’s report was “bipartisan.” I corrected him – pointing out that it’s “non-partisan.” Or at least it’s supposed to be.  He graciously accepted the point.

• Dr. Campbell acknowledged the importance of physicians (both practicing and those in the realms of both clinical and academic research) working with industry.  That’s nice.  But when I pointed out to him that physicians who do so (and particularly in the great Commonwealth of Massachusetts) are increasingly viewed as tainted – if not as outright criminals – he had no answer.

• My point to Dr. Campbell (and to all members of the COI Polloi) is that actions (often ones with political intent) often have unintended consequences (often on the public health).

In my concluding remarks I made the point that, when it comes to “transparency,” we need to weigh “interest versus benefit." That, as with drugs and devices, we must consider the “safe use” of transparency.

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Byron the "Brandjacker?"

10/06/2009 09:57 AM |

Word on the street (or, more precisely, on the Hill) is that Senator Dorgan is going to offer an importation amendment to the forthcoming (maybe) Big Kahuna health reform legislation.  Bad idea.  It’s time to introduce the Senior Senator from North Dakota to “brandjacking.”

According to an article in Pharma Times,  “A new report has highlighted the rise of pharmaceutical “brandjacking” for popular drugs, which is causing health concerns and damaging the reputation of the sector.” The analysis, published by MarkMonitor, highlights “a parallel online system of pharmaceutical supply and demand” which is being fuelled by continued growth in listings for medicines on business-to-business exchange sites as well as increased traffic to illicit pharmacies.”

As a result, consumers are turning to the internet, says the report, with people visiting both legal and illicit online pharmacies. Also, offshore manufacturers “increasingly embrace B2B exchange sites to sell bulk quantities of branded prescription drugs, often of suspicious quality.” Therefore, cost savings and efficiencies of e-commerce “become even more attractive, presenting a tempting opportunity for online fraud and brand abuse."

MarkMonitor chose six leading prescription drugs and examined nearly 20,000 instances of cybersquatting, the practice of abusing trademarks within the domain name system, a rise of 9%.

The report noted that of the 2,930 online pharmacies found in the study, only four were certified in the VIPPS program by the National Association of Boards of Pharmacy. Furthermore, the non-VIPPS sites offered discounts as high as 90% from the prices offered by certified websites, which indicate, “that the products are of suspicious quality.”

Importation anyone?

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Gems on REMS: A Cool and Refreshing Draft (Guidance)

10/06/2009 09:46 AM |

I was pleased to be both a co-chair and a speaker at this year’s Drug Safety Summit. (And particularly so, since we were joined by Sir Alasdair Breckenridge, Chairman of Great Britain’s MHRA -- the Medicines and Healthcare Products Regulatory Agency.)

My panel was ably moderated by Brian Harvey (Sanofis-Aventis and a former colleague from my FDA days). The other panelists were Meredith Manning (Hogan & Hartson) and Florence Ho (Celgene – and another former FDA colleague). 

The topic was “Achieving Predictability and Transparency in REMS.  Some of the discussion points:

* REMS must be viewed as a “win/win” situation for the agency (it can now move forward and approve drugs with higher risk profiles and have a more direct path for post-market surveillance), for sponsors (who can have their drugs approved with greater alacrity), physicians (who will – at least in theory) have a more complete view of risks and benefits, and patients (who will have additional therapeutic options and will now – at least in certain circumstances – become more complete part of the compliance/adherence proposition).

* Much discussion over where in the drug development process REMS should surface.  Acknowledgement that this cannot be done in the absence of data – and confusion as to how to deal with early (even Phase II information) that might be REMS relevant.  And “confusion” meaning both scientific uncertainty and internal confusion and discomfort.

* Evident frustration about validated tools (the absence thereof).  But this was at least somewhat assuaged by the timely release of the FDA’s draft guidance on “Format and Content of Proposed REMS Assessments, and Proposed REMS Modifications.”  And it was a cool and refreshing draft indeed.

* And, speaking of draft guidance and validated tools – what about timeliness and the potential for (are you sitting down) – user fees for REMS. Yes, of course REMS development and approval is part of the NDA process.  And, yes, they should (at least in theory) be covered under PDUFA fees. But, hey, just thought I’d mention it.

* The issue of both “class” REMS and REMS for generics – the latter combined with the important issue of the intellectual property and patent rights of the innovator.

* Continued discussion as to whether or not companies should wait until the agency asks – or if sponsors should preemptively (you should excuse the expression) provide an outline of a potential REMS plan.  This is important not just as an issue of timeliness (as opposed to having the agency introduce the topic in a complete response letter), but also of responsibility.  If, as we all want to believe, the FDA must be both regulator of and colleague to industry, then what are the responsibilities of a sponsor relative to (among many other things) surfacing the REMS issue – and at what point in the process. 

Nobody said it was going to be easy.

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Wisdom. Common Sense. And a Sense of Humor.

10/05/2009 05:12 AM |

Last Wednesday I chaired the Fourth National FDA Regulatory Symposium. Being the chair gave me the privilege to introduce the event’s keynote speaker, FDA Commissioner Peggy Hamburg.

By way of introduction, I pointed out that everybody benefits from an FDA that leads. This means the agency has to be out in front of every issue for which it is responsible.
Every specific action the agency takes is an opportunity to speak to a larger public health issue. When the FDA confidently leads, other stakeholders follow with their expertise, resources and sense of duty. The FDA must be seen as leading rather than simply participating in the process.

As a former New York City Health Commissioner, Dr. Hamburg has the opportunity to bring to the FDA the ability to view regulatory issues from the viewpoint of the man on the street, the patient -- the consumer.  And there are issues aplenty:

•    There’s the question of REMS plans.
•    And complete response letters.
•    And the transparency of complete response letters.
•    And biomarkers.
•    And guidance on off-label promotion.
•    And “net impressions” of DTC materials
•    And oversight of social media.
•    And of clinical trials.
•    And of adaptive clinical trials.
•    And follow-on biologics.
•    And bioequivalence for generics.
•    And GMPs
•    And drug importation.
•    And counterfeiting.
•    And companion diagnostics.
•    And the regulation of diagnostics.
•    And 510(k) reform.
•    And food safety and security.
•    And dietary supplements.
•    And nutritional health claims.
•    And tobacco.
•    And early safety signal communications.
•    And pandemic preparedness.
•    And greater international harmonization.
•    And the balance of predictability vs. ambiguity.
•    And food from the progeny of cloned animals.
•    And the FDA’s working relationships with industry and academia.
•    And the Reagan/Udall Foundation – wither the agency’s Critical Path program?

As Walter O’Malley – the man who moved the Brooklyn Dodgers to Los Angeles once commented, “The future is just one damn thing after another.”

The Commissioner began her remarks by commenting, “It’s a lot easier to ask the questions then to answer them.”  Zing,

Some additional thoughts from Dr. Hamburg:

* Concerned that the agency “is under-appreciated by the public”  (a recent poll shows that, among government agencies, the FDA ranks just one notch above the IRS) “and under-resourced.” In fact, she mentioned that she was going to OMB on Friday (October 2) to defend the FDA’s budget proposal for the coming fiscal year.  I promised to pray for her.

* The FDA’s most valuable assets are the “extraordinary public servants” who work at the FDA.  Can’t repeat that too many times.

* That to be FDA Commissioner requires “wisdom, common sense, and a sense of humor.”  Well said.

* The urgency of the FDA’s Critical Path program and “the urgency to fund robust 21st century regulatory science. “ She aptly defined the agency’s role as “Reviewer, Approver – and Catalyst. And, “We must advocate for it.”

* “Success is not measured in warning letters.” Amen – and courageous of her to say so.

* Similarly, and relative to foreign drug manufacture, “The FDA will never be able to assure safety all on our own.” And that there must be “shared responsibility for global drug inspections.”

* During the Q&A she was asked whether or not the FDA would add comparative effectiveness as a third leg to the approvals process.  Her smart response was that the FDA should find ways to share its data with researchers in order to “enrich understanding.” Short answer to direct question – no third leg.

* Per the FDA’s initiative on transparency (led by Deputy Commissioner Josh Sharfstein), Dr. Hamburg said she hoped to have some initial (“incremental”) recommendations by November.  Stand by on that one.

Thank you Commissioner.


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Moving Generics To the Critical Path: To BE or Not to BE

10/05/2009 01:42 AM |

The AAPS conference regarding extended or modified release formulations of drugs and therapeutic equivalence raised many important public policy questions.  The AAPS conference material  noted that:

"Demonstration of bioequivalence (BE) between drug products can be made using blood level measurements, pharmacodynamic studies, clinical trials, and/or in
vitro studies. The US regulations deem drug products therapeutic equivalents (TE) if they are both pharmaceutically equivalent and bioequivalent."

But it became clear that current standards of  BE do not add up to TE because we know more about the impact of individual variation in how we absorb and process drugs now than when the generic drug reforms were enacted in 1984.   So the question is, as Kamal Midha, Ph.D. of University of Saskatchewa, who spoke about existing standards for TE of sustained release products: are current regulations for measuring BE enough?

More to the point: if the public and the FDA are demanding more evidence about the safety and reliability of new products pre and post market (including more information the pharmacodynamics and phamacokinetics of such products), why shouldn't such information be used to establish TE of generic products, particularly those where the amount of a drug released and when is essential to a drug's safety and effectiveness.  While it may be true that this issue only affects a handful of drugs, it is also true that these drugs are not only widely prescribed, they are also mostly prescribed in generic form.  And post market oversight of this growing market share is not a top FDA priority even as safety  has become an critical (path) FDA concern,

So at the end of the day (and the conference) it became clear that better standards for tracking the impact of modified release products with new tools is not to be ignored.  Rather than being a way for innovators to escape generic competition, the collection and monitoring of better measures of TE can improve the overall quality of medicines without significant costs to either part of the industry.   That is the goal and essence of the Critical Path.  To ignore or dismiss concerns about toxicity or adverse events of sustained release products because they are made by generic companies is to suggest that the financial interests of that industry is more important than the public health.  

This issue can, as the AAPS meeting demonstrated, can be explored in a way that uses science to clarify issues and stratify risk so that the most important public health issues relative to this product class can be addressed.
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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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