Legislation Will Expand FDA's Authority Over Postmarket Prescription Drug Safety

Armen Hareyan's picture

Prescription Drug Safety

The House Energy and Commerce Health Subcommittee on Tuesday by voice vote approved nine bills that would expand FDA's authority to regulate prescription drug safety, indicating that the legislation has "strong bipartisan support," Dow Jones reports. The bills are part of a package of legislation that would reauthorize the Prescription Drug User Fee Act, which expires Sept. 30 (Corbett Dooren, Dow Jones, 6/19).

FDA has proposed collecting $393 million from drug companies in 2008. The House version of the measure calls for an additional $225 million in fees from drug makers over five years, and the Senate version of the legislation (S 1082), approved last month, calls for an additional $50 million. According to the Wall Street Journal, much of the additional money would be used to fund drug-safety monitoring programs. Both the House and Senate versions would allow FDA to collect $287 million over five years in fees from medical device manufacturers (Corbett Dooren, Wall Street Journal, 6/20).



The package of bills would grant FDA the authority to take major actions -- if deemed necessary -- against drug manufacturers, including requiring safety studies, limiting distribution of certain prescription drugs and ordering label changes. The subcommittee amended a provision that would have required that all new drugs enter into formal risk-mitigation plans that would have included at least three years of annual safety reviews. Under the amended provision, FDA would have the authority to decide which new drugs should be required to enter into postmarket risk-mitigation plans.

The subcommittee also eliminated a provision that would have allowed FDA to place a three-year moratorium on direct-to-consumer advertisements for new drugs (Dow Jones, 6/19). The amended version of the bill approved on Tuesday still allows pre-review of DTC ads by FDA, but the agency would have the authority only to recommend changes, although it could require disclosures in an ad to prevent it from being false or misleading. Under the measure, FDA could fine drug companies that distribute false or misleading DTC ads up to $250,000 for the first offense and $500,000 for subsequent offenses (Edney, CongressDaily, 6/20).

Other Provisions

The subcommittee approved a substitute amendment to a clinical trials registry bill that would create a registry of ongoing clinical trials by drug and medical device makers, along with an online database of trial results. The subcommittee also approved a bill that would give priority to drug company applications for medical devices with pediatric uses, while granting FDA the authority to require pediatric safety studies.

In addition, the subcommittee approved an extension of a current law that grants six months of sales exclusivity to new pediatric uses of drugs, while eliminating a provision that would have limited that exclusivity to three months for drugs with already high sales (Armstrong, CQ Today, 6/19). Pre-emption clauses included in the draft bills, which stated that strict compliance with FDA rules would not protect pharmaceutical and medical device companies from product liability lawsuits filed in state courts, were eliminated amid criticism from Republicans. However, two of the bills contain pre-emption language Republicans have not opposed, according to subcommittee Chair Frank Pallone (D-N.J.) (CongressDaily, 6/20).

The full committee will vote on the bills on Thursday, with full House consideration likely in July (Wall Street Journal, 6/20). The bills might be consolidated into one omnibus bill, similar to the Senate version, Pallone said (CQ Today, 6/19).

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