PDUFA
oracknows | July 17, 2017Here we go again.
It's been a while since I've written about the cruel sham that is known as "right to try." Anyone who's been reading this blog a while (or even read the first sentence of this paragraph) knows that I'm not a fan of right-to-try laws. Basically such laws, which have sprung up like kudzu since the movement to pass them gained momentum three years ago, claim to allow terminally ill patients the “right to try” experimental therapeutics. Thus far, they have been sold to the public as giving terminally ill patients “one last shot” and touting how such laws could save some of their…
sb admin | December 4, 2007by Susan F. Wood, PhDÂ
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…
sb admin | November 21, 2007by Susan F. Wood, PhDÂ
FDA recently announced two draft guidances regarding advisory committees, one on public disclosure of financial conflicts of interests and the other on voting procedures.Â
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The one on disclosure of financial conflicts of interest has gotten a fair amount of attention as it begins to implement the FDA Amendments Act of 2007 (FDAAA) requirements on disclosure. This draft guidance which calls for public disclosure 15 days in advance of any meeting of financial conflicts of interest for which a waiver is sought and granted for participation in the Advisory Committee…
sb admin | September 21, 2007The House and Senate have both passed legislation that renews the FDAâs 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…
sb admin | September 14, 2007Â 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.Â
The first is the limitation of financial conflicts of interest by FDA Advisory Committee members. The House has adopted language that limits the ability of FDA to grant waivers to members of Advisory Committees (AC) who have financial conflicts to only 1 waiver per meeting of a committee. This was identical to an amendment offered on the…
sb admin | September 6, 2007Â By Susan F. Wood, PhDÂ
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…
sb admin | August 27, 2007Â By Susan F. Wood, PhD
 The Journal of Womenâs Health published a special report and an editorial last month on the FDAâs Office of Womenâs 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, âThe Food and Drug Administration Office of Womenâs Health: Impact of Science on Regulatory Policyâ 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…
sb admin | August 1, 2007The 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 …
sb admin | June 15, 2007This 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 couldnât answer at a hearing and about the provisions that should be in the bill but arenât. 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…
sb admin | May 23, 2007By Susan Wood
The recent study in the NEJM clearly points out that our drug safety system is in need of repair. We shouldnât 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 âbullyingâ 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…
sb admin | April 24, 2007When 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?
Weâve 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…
sb admin | April 20, 2007The FDA certainly wasnât the biggest newsmaker this week, but it did create some buzz in the blogosphere â mostly due to the Prescription Drug User Fee Act, or PDUFA, which is up for Congressional reauthorization. Matt Madia at Reg Watch and Merrill Goozner at GoozNews are tracking PDUFAâs progress through the Senate. Corpus Callosum has three posts on three New England Journal of Medicine editorials about PDUFA (here, here, and here). (Weâve got Susan Woodâs take on the editorials here; or, check out all our PDUFA posts here.) The Olive Ridley Crawl reports that proposed restrictions on new-…
sb admin | April 13, 2007By Susan Wood
Next week both the Senate and House are moving forward on legislation to reauthorize the Prescription Drug User Fee Act (PDUFA), along with other key FDA legislation. The Senate will be âmarking upâ a large omnibus piece of legislation that combines PDUFA with drug safety legislation, pediatric legislation, and medical device legislation. The version of the bill that has been released is nearly 300 pages long, and so far only takes small steps toward strengthening the Kennedy-Enzi drug safety bill introduced earlier this year.
If you want to learn some of the basics linking…
sb admin | April 4, 2007By David Michaels
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, gets skewered again â this time in a piece by Christopher Moraff in the American Prospect Online. (We've been covering the issue here at TPH; more materials on the link between PDUFA and the drug safety crisis are also posted on DefendingScience.org).
Following hot on the heels of yesterdayâs Washington Post/Bloomberg critique by Cindy Skrzycki, Moraff summarizes the shortcomings of PDUFA raised by the Institute of Medicine,…
sb admin | April 3, 2007By David Michaels
The campaign by policy experts to have Congress end the user fee system that funds FDA is picking up steam. The Prescription Drug User Fee Act (PDUFA) allows FDA to collect money from drug makers in exchange for faster reviews of their new products. But PDUFA makes the FDA dependent on the drug makers for a big piece of its budget, and the money comes with lots of strings â especially ones that limit FDAâs spending on drug safety. (Here is last week post on the NY Times editorial opposing PDUFA.)
In todayâs Washington Post Cindy Skrzyckiâs The Regulators column has a…
sb admin | March 23, 2007By David Michaels
It is starting to feel like a groundswell. Last week, a group of 22 experts on drug safety and regulation issued an open letter to lawmakers asking Congress not to reauthorize the Prescription Drug User Fee Act (PDUFA), the system that funds the Food and Drug Administrationâs drug review process. In that letter, we wrote âuser fees may appear to save the taxpayers money, but at an unacceptable cost to public health.â
Yesterday, at a House Energy and Commerce Oversight and Investigations Subcommittee hearing, chaired by Rep. Bart Stupak (D-MI) , several members suggested…
sb admin | March 15, 2007By David Michaels
In the wake of the debacles involving Vioxx, Ketek, and other dangerous drugs that should never have been approved in the first place, Congress is about to take up reauthorization of the user fee system that funds the Food and Drug Administrationâs drug review process. The system is governed by the Prescription Drug User Fee Act (PDUFA), which will expire this year. The FDA has asked Congress to reauthorize the program for five more years.
Yesterday, a group of 22 experts on drug safety and regulation issued an open letter to lawmakers asking them not to reauthorize the…