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Editor's Letter
FDA's Hypocracy

By Cindy H. Dubin
Managing Editor
Pharmaceutical Formulation and Quality
April/May 2002
Tel: 215-860-7800 ext. 13
Fax: 215-860-7900
E-mail: cindy@carpediemcomm.com

The hypocracy is almost too much.  First, FDA promises the pharmaceutical industry to speed up the new drug review process in exchange for tens of millions in fees--money that the agency will spend to upgrade technology, focus on counter-terrorism, and double its number of staffers who oversee safety monitoring of newly-released therapies.

"FDA is looking for money to fund reviews of post-marketing drug product evaluations," Susan Cruzan, an FDA public affairs specialist, told me.  FDA currently reviews lifesaving drugs in six months and most others in 10 months.

At a time when it is so expensive to review ever-more complex drugs--and drug companies are discovering fewer of them--FDA is getting fewer industry payments, contributing to a $30 million hit this past year.

The agreement between FDA and industry would increase user fee revenue from $160 million last year to $223 million next year and $260 million by 2007.  The additional fees will result in the drug industry paying more than 51% of the costs to review and approve medications.

Drug companies have already paid millions in user fees that help fund FDA product reviews, under the Prescription Drug User Fee Act (PDUFA).  That law expires on September 30 and Congress is now debating how, and whether, to renew it.

Carl Feldbaun of Washington, DC-based Biotechnology Industry Organization, an association representing biotech companies, says the FDA/industry agreement benefits both sides and "the patients waiting for new products."

"It is not uncommon to reach out to our constituents," says Cruzan.  "We are working with industry to meet its needs and ours."

But Rep. Henry Waxman (D-CA) contends that the new agreement between FDA and pharma does not provide enough money for drug safety.  He notes that industry is not keeping promises to conduct further safety studies of newly marketed drugs: A report delivered to Congress in March shows that happens with only 37% of regular drugs, 15% of biotech products.

Which brings me to my second point: FDA just suspended the Pediatric Rule, requiring safety testing of adult medicines prescribed to children.  Under the Best Pharmaceuticals for Children Act (signed into law in January), Congress reauthorized financial incentives--six-month patent extensions--for manufacturers to conduct those studies, via funding by the National Institutes of Health. This move came after groups like the Association of Physicians and Surgeons, Competitive Enterprise Institute and Consumer Alert Group sued FDA for requiring manufactures to perform their own studies.  FDA will spend the next two years deciding if the Pediatric Rule incentives will stay in effect.

House Democrats complained to President Bush that the action would halt "an important regulation that protects children from potentially unsafe and improperly dosed medications," adding that the new law is "no substitute for requiring drug makers to perform safety studies."

Cruzan even admits to me that the million dollar question is whether or not this move shifts the burden of testing to manufacturers.  "The fact is that manufacturers should always be testing their drugs and their role is to obtain information on drug use," she says.

So, while on one hand, FDA claims it needs funds to enhance safety monitoring of new drugs, the agency pulls a complete 180 and disregards the safety of children for already-approved drugs that were developed with adults in mind.  Does no one see the hypocracy here?

As a pharmaceutical reporter, I'm aware of obstacles surrounding drug approval.

But as a parent, I'm outraged the FDA and pharma--would for a second--consider testing medicines and vaccines meant for children unnecessary!


picture of U.S. Food and Drug Administration logo

Best Pharmaceuticals for Children Act

Table of Contents



 Pediatric Exclusivity Legislation

This legislation has been cleared by Congress and will soon become law.



Letters to the Hill

September 17, 2001

The Honorable Jim Greenwood
2436 Rayburn House Office Building
Washington, DC 20515-3808

Dear Congressman Greenwood:

RE: Best Pharmaceuticals for Children Act




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