US Senator Wants To Probe FDA Fast Track Program
11 CommentsBy Ed Silverman // January 11th, 2008 // 7:39 am
Sherrod Brown, a Democrat from Ohio, has asked the research arm of Congress for information on the Fast Track designation to help determine whether a case exists for changing or eliminating the 10-year-old initiative that was intended to speed the availability of drugs for serious diseases, The Cleveland Plain Dealer reports.
The senator filed the request with the Congressional Research Service following a series in The Plain Dealer last month that concluded the FDA designation provides little actual benefit to consumers. The paper found that the designation has amounted to a government blessing, which has served as a marketing tool for drugmakers and a boon for investors looking to make quick money on the stock market.
Brown says the research will cover the various FDA programs to develop and review drugs and will help provide an assessment of Fast Track’s impact in preparation for discussions with senate colleague Edward M. Kennedy, a Massachusetts Democrat. Brown is a member of the Health, Education, Labor and Pensions Committee chaired by Kennedy.
“We’ll have a better understanding then, when I go to Kennedy and his people to talk about this,” Brown said. “They can see what they want to do then.” Congress approved the Fast Track designation in 1997 as part of extensive legislation to streamline the system for approving drugs and medical devices.
Kennedy played a major role in the creation of the designation. According to press reports at the time, he worked closely with the Genzyme, a Boston biotech that was a driving force behind the measure. A Kennedy spokeswoman says patient groups advocated for the designation, and the senator supported it because people were “suffering and dying needlessly.”
But if profiting on the stock market has been an unintended consequence of Fast Track, Congress should make necessary changes, Kennedy now says.
“Fast Track designation is meant to speed the review of urgently needed medicines, and it should not be abused to artificially inflate a company’s profits,” Kennedy says in a statement provided by his staff. “Congress should see that the Fast Track process is not abused and retains its intended purpose of seeing that important new medicines reach the patients who need them without undue delay.”
Since 1998, The Plain Dealer’s examination found, Fast Track announcements for almost 200 drug treatments triggered one-day stock price increases that averaged 10 percent. The announcements also created quick profit opportunities for day traders and hedge funds, driving one-day increases in shares bought and sold to an average of 1,300 percent. Frequently, company announcements erroneously suggest the designation is an indicator that a drug is likely to be approved.
A top FDA official acknowledged that Fast Track gives drug companies access to the same programs that were in place before the designation and provides no unique benefits to speed the development and approval of drugs.
Dan
With fast track designations and the FDA, it’s my understanding that pharma companies who have this happen with thier pending products actually pay the FDA in order to receive such a designation, regardless of the level of perceived necessity of the availability of the med.
Matthew Holford
This appears to contradict the arguments for NICE to be fast-tracking drugs onto the NHS. I wonder which MPs it was, who composed the report? I know of at least four MPs in the House who are GSK shareholders, including a member of the Opposition front bench!
Matt
Bob Freeman
Matt, thanks for your comments. My recollection, and correct me if it is no longer the case, is that NICE has functioned fairly well in releasing its recommendations. I also recall that NICE prided itself in being fiercy independent from pharma companies, and that this independence has been a thorn in pharma’s side since NICE was started. It looks as though their (pharma’s) strategy has become one of using lobbyists to influence MPs to make their attack.
Bob Freeman
Dan, all pharmas pay a fixed fee to the FDA for its reviews (PDUFA). The decision to award a fast track or expedited review is independent of PDUFA and is based on the clinical signficance of the drug.
I have forgotten the amound per NDA but I believe it’s approaching $1 million. PDUFA was set up and renewed to supplement the FDA’s annual budget, which was largely viewed as inadequate to handle the workload.
Atlex
The comparison between NICE and FDA is not really meaningful. The agency that is comprable to FDA is the EMEA. NICE is more responsible for reimbursement decisions as opposed to clinical safety.
Bob Freeman
Agree, Atlex, they aren’t comparable for that reason (FDA vs. NICE). NICE is more comparable, and it is a bit of a stretch to say this, to our CMS’ making coverage decisions for Medicare.
Hank
So who, _precisely_, decides whether a drug is fast-tracked or not?
We understand it began as part of FDAMA, but which department(s) within FDA/CDER actually makes the decision?
Hank
Partly answering my own questions, there is an overview of the process at
http://www.fda.gov/CDER/GUIDANCE/5645fnl.htm
It appears that the relevant medical branch of OND makes the decision if sponsor has indicated it is applying for fast-track in its IND application.
In the meantime, there is another interesting document that differentiates fast-track, accelerated, and priority reviews - all different processes.
Matthew Holford
Bob,
To be honest, NICE hasn’t really come under my radar, as I’ve “sauntered serenely across the fetid landscape that is drugs regulation”(1). As it acknowledges itself, aside from its role in the approval of drugs for the NHS, its opinions and recommendations are of persuasive authority only. In other words, failing to follow them won’t bring down the full weight of anything particularly! I would have to clarify, but I think that if a doctor failed to follow some NICE guidance, then the doctor’s clinical judgment would be held to supersede anything that NICE had suggested.
Nevertheless, the government, in the shape of the NHS, is a mighty big customer of the Worshipful Company [of Apothecaries] (my nickname for Big Pharma), and NICE gets in the way of patients having the latest and best drugs (TM The Worshipful Company). Alternatively, it prevents the taxpayer getting fleeced, paying for drugs that are no better than those already on the market.
Actually, you’ve pricked my curiosity: I think I’m going to try to clue myself up on NICE’s operations - it might be a useful ally. If so, it stands alone against the combined weight of regulator (MHRA), industry lobbyist (ABPI), and the Department of Health itself, it seems.
Matt
(1) Quoting myself from an ill-tempered letter I wrote to Prof Sir Alasdair Breckenridge, the MHRA’s Chair.
Bob Freeman
The UK has always been an “interesting” market: physicians are notoriously conservative in adopting new technology and reluctant to change their prescribing practices. I’m not so sure NICE has had that much impact on delaying innovation, since British physicians are skeptical, at best.
I remember working on a newer AIDS drug a few years ago. The uptake was really slow in the UK. After digging a bit, we found that physicians wanted all HIV/AIDS patients on the standard antiviral drug before expanding into newer therapies. (This was also couched in terms of the RHA budgets.). They also valued social services such as housing, hospice, berievement services, etc. as equally important services. (I salute this perspective, by the way)
In my opinion, pharma loves NICE when they issue a positive review and detest it when it doesn’t, which is pretty typical.
Matthew Holford
NICE has three areas of responibility:
a) Clinical Guidelines;
b) Technology Appraisals; and
c) Public Health Guidance
There appear to be three discrete branches of NICE: the Centres for Public Health Excellence, Health Technology Evaluation and Clinical Practice. As such, Clinical Guidelines are seen as something separate to Technology Appraisals, and, as I suggested, “coalface” decisions are still the remit of healthcare professionals (see “Applying NICE Guidance,” in the link, below).
It’s as clear as mud, to me, but it looks as though NICE, through its Centre for Health Technology Evaluation, conducts appraisals on drugs and whatnot, and the recommendations of these appraisals are then binding on the NHS nationally (until the recommendation is handed down, local NHS trusts are free to make their own decisions). See “Medicines and Devices,” below:
http://www.nice.org.uk/aboutnice/whatwedo/niceandthenhs/nice_and_the_nhs.jsp
Anyway, it seems to be the Centre for Health Technology Evaluation that creates the issues for the Worshipful Company! There’s more detail about Technology Appraisals, here:
http://www.nice.org.uk/aboutnice/whatwedo/abouttechnologyappraisals/about_technology_appraisals.jsp
Matt
PS Andrew Dillon is the CEO, so you may want to add him to your Christmas card list!