FDA Overhaul Legislation Would Improve Prescription Drug Safety

Armen Hareyan's picture

Prescription Drug Safety

The House on Wednesday voted 403-16 to approve a bill that would expand FDA oversight of prescription drug safety and reauthorize the Prescription Drug User Fee Act, which expires on Sept. 30, the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times,7/12). FDA has proposed that pharmaceutical companies pay $393 millionin user fees in 2008. The legislation calls for an additional $225million in user fees from pharmaceutical companies over five years. Inaddition, the bill would reauthorize the Medical Device User Fee andModernization Act, which also expires on Sept. 30. FDA would receiveabout $287 million in user fees from medical device companies over fiveyears.

Rx Drug Safety Provisions

The legislationwould allow FDA to require pharmaceutical companies to conductpostmarket safety studies of new medications, limit distribution ofcertain treatments and order product label changes. FDA could finepharmaceutical companies as much as $250,000 for a single violation ofthe requirements and as much as $1 million for several violations. Inthe event that pharmaceutical companies do not address the violationsafter they receive notice from FDA, the agency could fine them as muchas $10 million for a single violation and as much as $50 million forseveral violations.

In addition, the bill would allow FDA torequire new medications to enter postmarket risk-mitigation plans. FDAalso could review and recommend changes to direct-to-consumeradvertisements for new medications and could require disclosures inpotentially false or misleading ads. The legislation also wouldestablish prescription drug safety requirements for FDA.

Underthe bill, FDA would have to report to Congress in cases in whichrecommendations for agency safety reviewers are not accepted. Thelegislation also would establish a "unique identifier number" for allmedical devices that would allow FDA and health care providers to trackthe devices for potential problems (Kaiser Daily Health Policy Report,6/22). The bill allows FDA to approve generic versions of medicationsregardless of whether manufacturers of the brand-name versions raisesafety concerns or other issues (Edney, CongressDaily, 7/12).


House Energy and Commerce Health SubcommitteeChair Frank Pallone (D-N.J.) said, "Over the past few years, it hasbecome clear that consumers have been placed in harm's way because ofthe failings of the public health system" (Los Angeles Times,7/12). He added, "The legislation will lay the groundwork for restoringpublic confidence in the FDA by giving it the tools it needs tosafeguard the public health."


The Pharmaceutical Research and Manufacturers of Americasaid that the legislation "will preserve -- and even strengthen -- theFDA's ability to do its job." PhRMA President Billy Tauzin said,"Patients will continue to have timely access to innovative therapies,and they can be assured that the medicines they receive are reviewedunder the most rigorous standards in the world today" (Cohen, Newark Star-Ledger, 7/12).

Differences With Senate Version of Bill

The legislation moves to conference committee to reconcile differences with a similar bill (S 1082) approved by the Senate in May. According to the Times,the House version of the legislation "follows the same basic approachto safety as the Senate version" but "would give the FDA strongerregulatory powers in some areas."

Both versions of the billinclude a provision that would establish a computerized network to scanpublic and private health insurance and pharmacy records forindications of safety issues with new medications, but the Houseversion does not include benchmarks for implementation of the networkin the Senate version (Los Angeles Times, 7/12).

TheHouse and Senate versions of the legislation also differ on the numberof FDA advisory committee members with financial conflicts of interestwho could receive exemptions, and the "fines in the Senate bill aremuch smaller," CQ Today reports (Armstrong, CQ Today, 7/11).

Generic Biotech Rx

The House version of the bill does not include a provision in theSenate version that would allow FDA to approve generic versions ofbiotechnology medications. Pallone on Wednesday said that members ofthe conference committee would consider such a provision in the finalversion of the bill in the event they can reach a consensus. "I don'twant to be too positive," Pallone said (CongressDaily, 7/12).

House Energy and Commerce CommitteeChair John Dingell (D-Mich.) said that he does not support such aprovision in the final version of the legislation. "There's really norecord to justify that kind of action" for the House, which has notdebated legislation that would allow FDA to approve generic versions ofbiotech medications (Wilde Mathews, Wall Street Journal, 7/12).

According to the Times,whether President Bush would veto the final version of the bill remains"unclear," as the administration has "said it agreed with the goals ofthe legislation but had serious concerns about aspects of the riskplans." The administration also has said that the final version of thelegislation should not include a provision to allow FDA to approvegeneric versions of biotech medications (Los Angeles Times, 7/12). Pallone said that he expects the conference committee to begin negotiations almost immediately (CongressDaily, 7/12).


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