[CarolynS]

FDA, Industry Reach Generic Drug Fee Agreement

The New York Times, Published August 16, 2011

U.S. regulators and generic drugmakers have reached a compromise agreement for a user-fee program that would require the companies to pay some $299 million in the first year to accelerate drug approvals.

The Food and Drug Administration has been in negotiations with the generic drug industry since February to establish a user-fee program similar to one in place for brand-name drugs and medical devices.

[RLSmi]

Originally Posted by digger

FDA, Industry Reach Generic Drug Fee Agreement

The New York Times, Published August 16, 2011

U.S. regulators and generic drugmakers have reached a compromise agreement for a user-fee program that would require the companies to pay some $299 million in the first year to accelerate drug approvals.

The Food and Drug Administration has been in negotiations with the generic drug industry since February to establish a user-fee program similar to one in place for brand-name drugs and medical devices.

I first heard about the user-fee arrangement between Big Pharma and the FDA at the first International Parkinson's Congress in DC in 2006. The context was a panel discussion about the Parkinson's Pipeline in which our own Perry Cohen and Peggy Willocks were participants. The subject under discussion, as I recall, was the length of time required for trial drugs to pass through the process to final FDA approval. When I heard this arrangement described, it sounded so blatantly corrupt that I stood up and asked, "How long has this been going on?" It was then patiently explained to me by someone, maybe it was Perry, that the extra administrative load on the FDA created by the approval process required the hiring of additional personnel, and that the drug companies agreed to "help out" by paying a user fee to facilitate speeding up the flow through the pipeline. I was also assured that this practice had been going on for a number of years.
This arrangement probably makes perfectly good business sense, but the potential for serious conflict of interest seemed then, and still does to me, to be obvious.
Now we find that the generic drug manufacturers will be ponying up for the same scam, and the cost will, as with the brand name drugs, be passed on the patients.

What a world!

Robert

[lurkingforacure]

Originally Posted by RLSmi

I first heard about the user-fee arrangement between Big Pharma and the FDA at the first International Parkinson's Congress in DC in 2006. The context was a panel discussion about the Parkinson's Pipeline in which our own Perry Cohen and Peggy Willocks were participants. The subject under discussion, as I recall, was the length of time required for trial drugs to pass through the process to final FDA approval. When I heard this arrangement described, it sounded so blatantly corrupt that I stood up and asked, "How long has this been going on?" It was then patiently explained to me by someone, maybe it was Perry, that the extra administrative load on the FDA created by the approval process required the hiring of additional personnel, and that the drug companies agreed to "help out" by paying a user fee to facilitate speeding up the flow through the pipeline. I was also assured that this practice had been going on for a number of years.
This arrangement probably makes perfectly good business sense, but the potential for serious conflict of interest seemed then, and still does to me, to be obvious.
Now we find that the generic drug manufacturers will be ponying up for the same scam, and the cost will, as with the brand name drugs, be passed on the patients.

What a world!

Robert

$299 million would pay an awful lot of salaries for FDA employees to handle the apparently overwhelming number of drug applications. Do criminal defense lawyers get to pay the prosecution attorneys to "help out" with their burgeoning caseload? Maybe I'm missing something, but it seems like they could come up with a better way to handle this other than this, particularly when the public trust of the FDA is, IMHO, at an all-time low.

[olsen]

The Prescription Drug User Fee Act (PDUFA) was enacted in 1992 and renewed in 1997 (PDUFA II), 2002 (PDUFA III), and 2007 (PDUFA IV)

[tremorgrrrl]

Before the PDUFA was passed in 1992, the average wait time for the FDA to review a new drug application was 31.3 months. And this is after about 5 years of clinical trials.

It was in response to criticism from patients, physicians, and pharmaceutical companies about these lengthy delays in the FDA's new drug application reviews that prompted Congress to pass the PDUFA. Since passage of the Act, the average review time has decreased to 10 months for standard drugs (and 6 or less months for critical drugs). User fees now make up about 65% of the FDA's costs of reviewing new drug applications.

The user fees aren't cheap. In 2008, a new drug application with clinical trial data was $1.2 million.

Is this the best way to handle new drug reviews? Given our current economic climate, it is hard to image any change in the near (or even middling) future.

Tremorgrrrl

[tremorgrrrl]

A final comment....

Canada also instituted user fees for its new drug application reviews two years after the United States passed PDUFA. The Canadian law, unlike the US law, replaced government money with user-fee generated revenues; in the US, the user-fee program is intended to supplement the FDA's appropriations. Moreover, Canada has a relatively opaque drug approval processes; with increased industry participation through user-fees, this is unlikely to change. In the US, by contrast, considerably more information about the drug approval process (and about specific new drug applications) is and has always been publicly-available. Such transparency (which accounts for yet another cost in the approval process) is an important counter-balance to keep actual and perceived biases in the approval process in check.

Tremorgrrrl