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U.S. Senate begins debate on law to overhaul much of pharmaceuticals regulator's work

U.S. Senate begins debate on law to overhaul much of pharmaceuticals regulator's work

Stronger oversight of the safety of drugs is in, but generic biotech drugs are out for now as the Senate debates new fees to be paid by pharmaceutical companies seeking approval for new medicines.
Lawmakers have seized on the legislation as the best shot in years to overhaul the Food and Drug Administration.
The final shape of Senate legislation to reauthorize the Prescription Drug User Fee Act remained very much in flux as debate began Monday. Lawmakers prepared to offer up a flurry of amendments during the week's debate.
Both the FDA and the drug industry have expressed hope for a "clean" bill unfettered by such additional provisions. However, in the aftermath of the 2004 withdrawal of the painkiller Vioxx, the FDA has drawn renewed scrutiny from Congress. As a result, lawmakers in both the Senate and the House of Representatives are using reauthorization as the vehicle to overhaul not only the FDA's handling of drug safety but other issues as well, including food safety.
Since it was enacted in 1992, the act, commonly known as PDUFA or "puh-do-fah," has authorized the FDA to collect fees from drug companies to defray the cost of reviewing their products. The law also requires the agency to stick to certain performance goals that make the approval process faster and more predictable.
The law, which has been extended twice for five years each time, expires Sept. 30 unless renewed by Congress.
In the Senate, a bill by Sens. Edward Kennedy, a Democrat, and Republican Mike Enzi would roll into PDUFA additional legislation to reauthorize a related user-fee program for medical device manufacturers. It also includes legislation meant to ensure that drugs and devices for children are safe and effective. It further proposes increased public disclosure of information from studies of both drugs and devices.
Most significantly, however, the bill would require the FDA to do more active surveillance of drugs already on the market for potential problems. It also would require special plans to accompany approval of some new drugs to manage any serious risks associated with their use.
"We have the opportunity this week to renew key FDA programs, and to ensure that the FDA continues to operate with new tools to ensure that safety is forefront of every decision during the life of a drug," Enzi said.
For now, the bill does not include any mechanism that would allow FDA to approve generic versions of pricey biotech drugs. The Generic Pharmaceutical Association remains optimistic such legislation will reach the Senate floor this year, the industry group's president and chief executive, Kathleen Jaeger, said.
Nor does it include any provisions that would allow for the importation of prescription drugs. Still, another industry group, Pharmaceutical Research and Manufacturers of America, continues to warn that such a measure, if ultimately included, could expose patients to foreign counterfeits.
Other amendments under contemplation include bids to further clamp down on conflicts of interest among FDA's expert advisers, guarantee agency scientists the right to publish their work without interference and subject medical marijuana to the same standards and penalties as any other drug sold to patients.
The Kennedy-Enzi bill also proposes a temporary moratorium on direct-to-consumer advertising of newly approved drugs, but only if the FDA should deem doing so would protect the public's health and safety while it gathers more information about any serious risks.
The FDA's proposal to Congress would have the drug industry pay $393 million (euro288.9 million) in annual fees; Kennedy and Enzi propose increasing that by another $50 million (euro36.75 million) to defray added drug safety costs. Overall, fees cover a majority of the FDA's drug-review budget, with federal dollars making up the rest. The FDA also has proposed to have medical device makers pay $49 million (euro36 million) next year in fees. The FDA's annual budget is roughly $1.8 billion (euro1.3 billion).