Drug Industry, FDA user-fee deal fails to fix drug Safety crisis; New laws and real funds are needed

 WASHINGTON, Jan. 11 /PRNewswire-USNewswire/ -- A proposed user-fee deal negotiated in private between the pharmaceutical industry and the FDA earmarks some funds for drug safety, but Consumers Union says the Administration must significantly fund comprehensive safety efforts, and Congress must pass new laws, to adequately protect the public from dangerous drugs.

"At a time when countless drugs have safety problems, it isn't enough to just rely on money paid by the pharmaceutical industry to fund needed drug safety reforms," said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports.

"To address the wholly inadequate drug safety system, consumers need a commitment from the Administration to completely fund drug safety, and new laws that will ensure we don't have any more Vioxx-type disasters," Vaughan said.

The FDA announced today that it reached an agreement with the drug industry on extending the Prescription Drug User Fee Act, or PDUFA. Congress first passed PDUFA in 1992 to speed up the drug approval process by approving drugs more quickly in exchange for the industry helping to fund the approval process. The original act has been extended twice and is slated to expire this year unless Congress reauthorizes it (PDUFA IV).

The proposal calls for industry to pay $393 million annually to the FDA, an increase of $87 million over the previous PDUFA agreement. Of the increase, $29.3 million is earmarked for drug safety efforts over the life-time of a drug.

Vaughan said designating some user fees toward post-market safety is a positive step, but noted it is still a fraction of the overall amount the drug industry pays FDA to get its drugs on the market quicker.

"Using a small portion of industry fees for safety sends a good message, but we must give FDA the power, and the resources, to adequately ensure safety," Vaughan said.

Consumers Union supports legislation introduced in the last Congress (S. 3807, HR 2090) that would reform drugs safety laws and give the FDA more power to require drug makers to perform post-market safety studies once problems arise. CU also backs public reporting of clinical trial results, so patients and doctors know about side effects and drug risks. Currently, the drug industry is not required to make trial results public.

"More funding for drug safety is critical, but to adequately protect consumers, the FDA has to have the authority to require the drug industry to do the safety work," Vaughan said.

The PDUFA proposal also hopes to collect $6 million in additional fees from industry to fund review of direct-to-consumer advertising. FDA said that within five years, it hopes to have advertisements reviewed within 45 days of submission to ensure they are accurate and balanced.

   

Vaughan said more vigorous review of DTC advertisements is a good step, but noted ads are submitted to the FDA for review on a voluntary basis, and drug companies currently can run ads as soon as they submit them.

 

"A company could blanket the airwaves with ads for 45 days before the

FDA finishes its review. Even if the ads are pulled, a lot of folks will

now be asking their doctor for that drug, which could have risks that

weren't fully explained," he said.