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【社会人文】参议院批准FDA关于增加新药检测议
Senate Approves FDA Bill Adding New Drug Monitoring
By JOHN GODFREY
May 9, 2007 2:12 p.m.
WASHINGTON -- The Senate on Wednesday passed 93 to 1 legislation that would require the Food and Drug Administration to monitor new drugs for at least three years after the regulator approves them.
The legislation moved after its sponsors made a number of concessions to the pharmaceutical industry, including blocking a proposal by Sen. Byron Dorgan (D., N.D.) to allow consumers to import prescription drugs from abroad.
The drug importation amendment won a 63-28 test vote last week, but Senate Education, Labor, Health and Pension Committee Chairman Edward Kennedy, of Massachusetts, argued for a watered-down version of the proposal. Mr. Kennedy cited a veto threat by the White House against Dorgan's amendment and said he didn't want to see the rest of the bill killed because of it.
Mr. Dorgan's proposal was modified and adopted, but lawmakers on both sides of the issue say that in its current form, the drug importation proposal will never take effect.
Mr. Kennedy also opposed an effort to make it harder to waive conflict of interest rules for scientists on drug safety committees.
Sen. Dick Durbin (D., Ill.) argued that his proposal was common sense. A committee overseeing drug safety shouldn't be stacked with scientists paid by the drug's manufacturer, Mr. Durbin said.
Mr. Kennedy countered that he understood the concern, but that Durbin's response would be overly constraining.
The underlying bill would require the FDA to establish a safety system to monitor new drugs for at least three years after they have been approved. Such provisions, aimed at boosting drug safety, are part of a broader bill by Mr. Kennedy, and Sen. Michael Enzi (R., Wyo.), that would renew a law allowing the FDA to collect fees from pharmaceutical and medical-device companies to help fund the agency.
A Tuesday-night deal on direct-to-consumer advertising had cleared the way for the final Senate vote.
"I worked for this compromise because I have serious concerns about the advertising provisions in the underlying bill, and I believe they would infringe on our first amendment rights to free speech," said Sen. Pat Roberts (R., Kan.).
Mr. Roberts negotiated with Messrs. Kennedy and Enzi on the compromise, which would impose civil monetary penalties for companies that produce ads that are false or misleading -- after they have been notified by the FDA and have been given an opportunity for a hearing.
Federal law that authorizes the FDA to charge industry user fees expires Sept. 30, the end of the 2007 fiscal year. The Kennedy-Enzi bill, known as the FDA Revitalization Act, would renew the law through 2012. User fees fund part of the FDA's annual budget. The fees are collected, for example, when companies file applications to the agency seeking approval of new products.
The fact that the user-fee law expires this year makes it almost certain that Congress will include tougher drug-safety provisions as part of a final bill renewing the fees.
Many of the drug-safety provisions were introduced as separate pieces of legislation amid congressional criticism about whether the FDA should have done more and sooner to warn consumers about the risks of the painkiller Vioxx. Merck & Co. pulled Vioxx off the market in 2004 after the drug was tied to an increased risk of heart attacks and strokes.
Any FDA bill that passes the Senate must eventually be reconciled with a yet-to-be introduced bill in the House of Representatives that would renew user-fee laws.
The FDA Revitalization Act also renews another law that gives drug companies incentives to conduct research on drugs for children. The bulk of drugs on the U.S. market were developed for adult consumption.
The main drug-safety component in the Kennedy-Enzi bill is a risk management program involving formal surveillance of medicines for three years after they are approved.
It would require the FDA to review the safety profile of all new chemical entities or new types of drugs at 18 months and then three years after they are approved. Under the program, the FDA would have access to public and private databases that track, among other things, reports of side-effects in patients. Other drugs, such as those currently on the market but subsequently approved to treat another illness, would be also reviewed for three years once they are approved for alternative use.
Since 1992, the FDA has raised some funding by charging fees to both medical-device and drug companies. The rest of its budget is funded through money appropriated by Congress.
The FDA has proposed collecting $393 million from pharmaceutical companies next year, but the Kennedy-Enzi bill would increase that amount by $50 million. The bill would also authorize the FDA to collect about $287 million in fees from medical-device firms over the next five years.
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作者:admin@医学,生命科学 2011-04-26 17:11
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