March 8

InfoMail for March 8, 2002



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News Stories on Human ResearchProtection and
Commentary by Vera Hassner Sharav

March 8, 2002 

FDA and Pharmaceutical Industry inPrivate Deal to Speed Drug Approval Process


According to the Washington Post, the FDA hasreached an agreement with the pharmaceutical industry to further speed up thedrug approval process. The privately negotiated agreement would expand the 1992Prescription Drug User Fee Act (PDUFA) which was enacted bring new drugs tomarket faster.

But that speeded-up process, The Los Angeles Timesreported in a two-year Pulitzer Prize winning series, led to the approval ofunsafe drugs that had to be recalled after they killed people.
(See "How a New Policy Led to Seven Deadly Drugs," by David Willman,LAT, Dec 12, 2000.
Click here to read this article.

The current proposed "modifications" would leadto the approval of drugs before their safety is even known. Thus, many, possiblyunsafe new drugs will be tested on millions of unsuspecting patients AFTER theirapproval by the FDA. Prescribing physicians and patients who assume an FDAapproved drug is safe, will essentially become unwitting subjects of a vast drugtrial.

One Congressman (Sherrod Brown of Ohio) observed:"With all due respect, this committee and this Congress jump when the drugindustry says ‘jump’; it rushes to pass legislation when the drug industry wantsit to pass legislation," "But we better not talk about drug pricing orthe impact of direct-to-consumer advertising on health care utilization. Thosetopics are taboo."



Deal to Boost Drug Approval, Oversight

By Marc Kaufman

The Food and Drug Administration has reached tentativeagreement with the prescription drug and biotechnology industries on a plan thatwould enable the agency to hire hundreds of new employees to speed drugapprovals and would substantially increase oversight of drug side effects aftermedications reach the market.

The agreement, negotiated in private but discussedpublicly yesterday at a congressional hearing on reauthorization of thePrescription Drug User Fee Act (PDUFA), is being reviewed by the Bushadministration and could be modified before being formally presented to Congressthis month.

But industry and government officials agreed yesterdaythat there will be a major increase in the amount drug companies pay as FDAdrug-approval user fees and a resulting expansion in the FDA workforce. Already,industry user fees pay the salaries of more than 1,000 agency employees.

That drug industry funding has allowed companies to havetheir new drug applications reviewed and approved much more quickly than beforePDUFA was passed in 1992, which has made the program popular with drugproducers. But some consumer groups have accused the FDA of being co-opted bythe industry money, saying the agency moves too fast on drug applications whilebeing dangerously reluctant to take drugs off the market when consumers beginexperiencing serious complications.

Testifying before the House Energy and CommerceCommittee’s health subcommittee yesterday, FDA Deputy Commissioner Lester M.Crawford said the PDUFA process has allowed U.S. drugmakers to become far morecompetitive and bring out many more new drugs than their European rivals.

He defended the agency’s safety record — saying thepercentage of approved drugs pulled from the market has not changed since 1992– but was also eager to report that the number of FDA employees reviewing sideeffects from drugs already on the market would increase most significantly underthe proposed plan. Other FDA officials later said the number of agencypost-marketing reviewers would double, to about 200.

The FDA has been meeting regularly for several months withrepresentatives of the Pharmaceutical Research and Manufacturers of America (PhRMA)and the Biotechnology Industry Organization (BIO) to negotiate how much theywould pay in user fees and how FDA procedures and timetables might be modified.Some members of Congress and consumer representatives complained yesterday aboutthe private nature of the meetings, because the subject was the operations of amajor government agency.

There was general support in the subcommittee forreauthorization of PDUFA, which was a major initiative of House Republicans inthe early 1990s. Republican members of the subcommittee stressed that PDUFAexpires on Oct. 1 and that FDA employees will be laid off if it is notreauthorized in time. They said a "clean" bill should be passed so theprocess will go quickly.

But some Democratic lawmakers asked critical questionsabout how aggressively the FDA regulates prescription drugs and aboutprescription drug pricing, and they indicated that those subjects should be partof the PDUFA reauthorization.

For instance, Rep. Sherrod Brown (D-Ohio) made clear thathe wants to link PDUFA to issues of drug safety and the availability of genericdrugs. He also raised the contentious issue of prescription drug costs.

"With all due respect, this committee and thisCongress jump when the drug industry says ‘jump’; it rushes to pass legislationwhen the drug industry wants it to pass legislation," Brown said. "Butwe better not talk about drug pricing or the impact of direct-to-consumeradvertising on health care utilization. Those topics are taboo."

Sidney Wolfe of the public interest group Public Citizen,who has criticized the industry user fees for years, said the new plan is noimprovement. Public Citizen has been particularly aggressive in pushing forgreater post-market surveillance of drug side effects, but Wolfe said theindustry-funded program is misguided.

"To think this money from the industry is a freelunch, to think that it won’t affect the process at FDA, is fantasy," hesaid.

Much of the testimony yesterday about FDA expansionfocused on the post-marketing surveillance, but industry officials later saidtheir greatest concern still is getting new drug applications through the agencymore quickly.

Carl Feldbaum, president of BIO, said his group hasconcluded that the FDA’s Center for Biologics Evaluation and Review is"seriously underfunded" because of the recent jump in applications fordrugs created through biotechnology, and that it needs more funds from userfees. He said his group wants some of the new money to pay for consultants hiredby the FDA to explain cutting-edge technologies to staff members.

Alan Goldhammer, PhRMA’s vice president for regulatoryaffairs, said his organization has also concluded that the FDA needs more userfees to support the drug approval process. While the number of agency employeesworking on post-market surveillance of dangerous side effects would increase by100 under the tentative plan, he said the number of new drug reviewers wouldincrease by "several hundred more."

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