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by Susan F. Wood, PhD 

It’s not often, if ever, that an FDA sponsored report calls out for more resources, more direct action and organizational change for FDA.  The recently released report (PDF) by the Subcommittee on Science and Technology for the FDA Science Board does just that.  Although I wouldn’t necessary agree with all of the recommendations, and would call out for a few more, the report identifies some of the real needs at FDA for strengthened science.  The FDA Science Board, an Advisory Committee to the FDA, has issued earlier reports, but none with the timeliness and potential impact of this one.  Most of the press coverage has been on the call for expanded resources – which are truly needed – but the report also identifies some of the scientific infrastructure needs that trail behind our expectations of this critical public health agency.  I don’t know if FDA expected this type of report, but hopefully it can be useful as a way to move the agency forward.

From the report:

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by Susan F. Wood, PhD 

FDA recently announced two draft guidances regarding advisory committees, one on public disclosure of financial conflicts of interests and the other on voting procedures

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The House and Senate have both passed legislation that renews the FDA’s user-fee system and enacts some important reforms. The process has been rushed because FDA is running dangerously low on funds; President Bush will need to sign the legislation today if the FDA is to avoid sending termination letters to one-fourth of its staff.

First, some background: In 1992, Congress passed the first Prescription Drug User Fee Act (PDUFA) and set up a system in which drug companies pay annual fees and fees for each prescription drug product they market, and these fees help fund the FDA’s process of reviewing new drug applications. PDUFA has to be reauthorized every five years, and advocates of drug safety and scientific integrity – including my colleagues at the Project on Scientific Knowledge and Public Policy – used the 2007 reauthorization process to push for reforms. (Go here or here for more details.) Under the current user-fee system, the FDA has devoted more resources to reviewing new drug applications and meeting new goals for review times, but its post-approval drug safety activities have suffered and some of its reviews have been rushed. Vioxx and other drugs that FDA has approved have turned out to have serious side effects and have been pulled from the market, and a 2006 Institute of Medicine report concluded that the agency needed significant reforms to improve drug safety.

Here are the important steps that the bill takes:

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 By Susan F. Wood, PhD

 Two things appear to be major bones of contention in determining the final version of what is now named the “FDA Revitalization Act of 2007″ (FDARA).  And they both related to public transparency and public accountability. 

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 By Susan F. Wood, PhD 

In an article in the New England Journal of Medicine today, Sheila Weiss Smith points out that the FDA has not been responsive to the Institute of Medicine (IOM) report on Drug Safety.  That study and its recommendations took on the question of how to improve our nation’s drug safety system, specifically through regulation by FDA.  In her Perspective article, Dr. Smith writes:

In general, the IOM implored the agency to “embrace a culture of safety” by increasing the priority accorded to the safety of patients. Such an emphasis could have ramifications for medical care that would be as broad and positive as those that the 1999 IOM report on medical error, To Err Is Human,2 has had for the health care system. Sadly, the FDA’s official response falls far short of what the American public expects and deserves.

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 By Susan F. Wood, PhD

 The Journal of Women’s Health published a special report and an editorial last month on the FDA’s Office of Women’s Health (FDA OWH) that provide information and insight into the multiple roles of such an office, and the importance of maintaining the scientific research funded there.  The special report, “The Food and Drug Administration Office of Women’s Health: Impact of Science on Regulatory Policy” identifies some of the major projects initiated by the FDA OWH, more than 100 studies costing more than $14 million over 10 years.  This is a very small amount compared to NIH or to what the regulated industry funds (billions each year), but is focused on elucidating data that can help the FDA make regulatory decisions that affect the health of both women and men.

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The Boston Globe, home town paper of  Senator Ted Kennedy, Chair of the Senate Health, Environment, Labor and Pensions Committee, ran two important commentaries on the FDA this week.

 First was an editorial  yesterday strongly urging Congress to pass a strong FDA reform bill, including restricting financial conflicts of interests for advisory committee members.

Today the Globe ran an oped coauthored by David Michaels and me, again calling for leaders in Congress to ensure that the final bill (it is now in “conference” between the House version and the Senate version) come out as strong  a bill as possible.

 Take a look, I hope the Senator does!

Susan Wood is Research Professor at George Washington University School of Public Health and Health Services, where she is part of the Project on Scientific Knowledge and Public Policy (SKAPP).

This week, Congress has been wrestling with the reauthorization of the Prescription Drug User Fee Act; Merrill Goozner at GoozNews reports from Capitol Hill about the questions that FDA Acting Deputy Commissioner for Policy Randall Lutter couldn’t answer at a hearing and about the provisions that should be in the bill but aren’t. Matt Madia at Reg Watch reports that FDA drafted the bill for Congress after numerous meetings with pharmaceutical industry representatives. (Check out our past posts on PDUFA for background.) Meanwhile, Bill Miller at DeSmogBlog notes that pharmaceutical companies may profit as the world warms.

For some good news, we can turn to Angry Toxicologist, who tells us that dioxin levels in the U.K. are dropping, and Laura Lindberg at RH Reality Check, who reports that teen males have become less sexually active and much more likely to use condoms since the late 1980s (the news in the post about sex education and reproductive health services is gloomy, though).

Elsewhere:

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By Susan Wood

The recent study in the NEJM clearly points out that our drug safety system is in need of repair.  We shouldn’t need these constant reminders, from Vioxx to Ketek and now to Avandia.  Indeed FDA reform legislation is moving through Congress as we speak.  But does it do what we need it to do?

The DrugWonks blog has accused those of us who are advocating for a more safety-focused FDA that is less dependent on restricted user fees of “bullying” the agency, but I only wish we were as powerful as they seem to think we are. The Senate bill, now known as S. 1082, the FDA Revitalization Act (new acronym: FDARA), unfortunately got weaker as it went through the process. 

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When you go to the Department of Motor Vehicles and pay your fee to register your car, are you allowed to negotiate with the DMV as to how the agency will use your fee? Of course not. So why is the drug industry allowed to negotiate with the FDA about how the agency will use the money it collects in fees paid for new drug applications?

We’ve written several posts already about the Prescription Drug User Fee Act (PDUFA), through which the FDA collects money from drug makers in exchange for faster reviews of their new products. (Go here for a list of past PDUFA posts, or check out the new white paper on PDUFA here.) We and many other members of the medical and public health have raised concerns about impact of PDUFA on drug safety; Christopher Moraff summarized them neatly in a recent American Prospect article:

User fees are not uncommon in federal agencies, but critics of PDUFA say that what distinguishes it is an unprecedented level of collaboration between the FDA and the pharmaceutical industry. Through protracted fee negotiations, the industry has a say in everything from how the money will be spent to setting up timetables for a drug’s approval — the equivalent, according to one former chief editor of The New England Journal of Medicine, of “putting the fox in the chicken coop.”

So, who does support the user fee system? None of the usual suspects, it turns out.
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