Gents, this lengthy article tends to show, once again, how symbiotic the machinations of the FDA and the Drug & Pharmaceutical Industry really are.
It also gives weight to my assertions in the previous post, doesn’t it?
What an unholy alliance. Small wonder that, allegedly,senior executives from the FDA often move straight across to the Drug companies, at board level, on retirement from the FDA.
Artical from: http://www.medpagetoday.com
BOSTON, April 13 — Hefty user fees from pharmaceutical companies account for some 40% of the FDA’s budget for new-drug reviews, but this scheme that spurs speedier approvals worries safety watchdogs.
Three opinion articles, issued by the New England Journal of Medicine ahead of a scheduled April 26 publication, tried to drive those concerns home. The so-called perspectives were aimed at Congress, which is reviewing the law that set up the user fees. The law is set to expire in September unless it is reauthorized now.
For instance, one of the perspectives pointed out that the 5% of the user fees permitted to go to postmarket surveillance is not even enough for a single study to investigate the cardiovascular safety of drugs used to treat attention deficit disorder.
Jerry Avorn, M.D., a professor of medicine at Harvard, asserted out that the FDA is unique in that it is the only regulatory agency that works “so cozily” with a trade group that represent the industry, in this case the Pharmaceutical and Research Manufacturers of America.
In his article, Dr. Avorn called for Congress to sever this relationship by requiring that “the FDA’s drug-related work to be funded by general federal revenues, rather than by the industry it regulates.”
The original law, enacted in 1992, allowed the FDA to levy user fees on drug companies, yet barred it from using those fees to monitor post-marketing safety. The law was re-authorized in 1997 but when Congress re-authorized it in 2002, about 5% of the fees were earmarked for post approval safety monitoring.
Dr. Avorn said that when the law was created in 1992 the FDA was regularly criticized for being too slow to approve new drugs-especially new AIDS drugs. In that climate, user fees seemed an ideal solution to eliminate perceived inefficiencies of government and speed up the FDA pipeline. The legislation established strict time limits for drugs to wend their way through the FDA process,
This time around, the FDA asked Congress to set aside 6.7% of the user fees to fund postmarketing studies. But in a perspective he co-authored, Brian L. Strom, M.D., M.P.H., of the University of Pennsylvania found that unsatisfactory.
“We agree with Dr. Avon’s position that ideally all funding should come from [general revenues], but practically speaking that is not going to happen at a time of budget deficits,” Dr. Strom said in an interview. “So what we are proposing is that Congress earmark more funds for the FDA to conduct its own safety studies-probably a number like $100 million.”
Dr. Strom and his University of Pennsylvania colleague, Sean Hennessy, PharmD., Ph.D., pointed out that under the current proposal the FDA is asking that $29.3 million of the $437.8-million it expects to collect in user fees in 2008 to be used for modernizing and transforming the drug-safety system.
To put that in perspective, they pointed out that Americans spent $188.5 billion on prescription drugs in 2004 and drug companies spent about $12 billion advertising prescription drugs that same year.
Yet the FDA could not afford “even a single large study of one recently noted safety signal that has major public health importance-the indication of possible cardiovascular risk posed by drugs for attention deficit-hyperactivity disorder,” they wrote.
In the third article, former FDA commissioner Mark McClellan, M.D., Ph.D., argued that the most effective fix for the FDA would be an overhaul of the postmarketing system by making use of available technology.
Dr. McClellan, now a visiting senior fellow at he AEI-Brookings Joint Center for Regulatory Studies in Washington, said that with electronic prescribing information and “the availability of increasingly detailed data on health care utilization and outcomes for insured Americans, we could implement a routine, systematic approach to active population-based drug surveillance that could identify potential safety problems much more effectively and relatively inexpensively.”
Instead of the five years that it took to reveal the excess cardiovascular risk seen with rofecoxib (Vioxx), a “statistically significant ’signal’ of serious cardiovascular risk could have been detected after less than three months of experience with rofecoxib” by the use of a now-feasible electronic surveillance network, with information on 100 million patients, he wrote.
Drs. Avorn and McClellan declared no financial conflicts. Dr. Strom said he served on the board of Medco Health Solutions, and received grant and/or consulting fees from Pfizer, Takeda, Amgen, Berlex, Merck, Novartis, Wyeth, Abbott, Aetna, AstraZeneca, Biogen Idec, Blue Cross and Blue Shield Association, Bristol-Myers Squibb, Centrocor, Cephalon, CV Therapeutics, Daiichi, Sankyo, Oscient, GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Sanofi Pasteur, Schering-Plough, Shire, TAP, Warner-Lambert, and from law firms representing Bayer and plaintiffs suing pharmaceutical companies. Dr. Hennessey reported research funding or consulting fees from Pfizer, Johnson & Johnson, Wyeth, Sanofi Pasteur and from law firms representing Bayer, Pfizer, and Eli Lilly as well as from law firms representing plaintiffs suing pharmaceutical companies. Drs. Strom and Hennessy are special government employees of the FDA, and Dr. Hennessy is a current member and Dr. Strom a past member of the FDA’s Drug Safety and Risk Management Advisory Committee.
Today’s Quote:
“If all the medicines in the world were thrown into the sea, it would be bad for the fish and good for humanity” O.W.Holmes, (Prof of Med. Harvard University)
