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FDA wins extra drug safety powers

The Upper House in the US passes legislation which will allow the federal government more power to monitor the safety of prescription drugs and has sent the measure to the Senate for final approval

The Upper House in the US has approved legislation which will allow the federal government more power to monitor the safety of prescription drugs and has sent the measure to the Senate for final approval.

The legislation, which was passed by 405 votes to seven, will allow the FDA to take a number of courses of action if it assesses that a drug carries a potential safety concern to the public: force companies to conduct new safety studies; and limit distribution or order label changes.

The agency will also be required to monitor drugs after they go on the market. In order for this to happen, the FDA would receive new funding. The bill would also force companies to make public some of the results from their safety studies.

Some Republican lawmakers have objected to provisions related to the liability faced by the pharmaceutical industry, but the Senate has faced enormous pressure to pass the measure, because it also renews funding for the FDA that will run out at the end of the month. The agency has said it would warn 2,000 of its approximately 10,000 employees about potential layoffs if the bill isn't passed by 21 September.

The bill includes a provision backed by House Democrats which could weaken a key legal defence used by pharmaceutical companies in plaintiff suits. The debate concerns the question of drug companies' protection against plaintiffs, claiming that they were injured by medicines.

The Bush administration supports the idea that FDA-approved drug labels pre-empt state law. Pharmaceutical makers have used this to protect themselves in legal cases, arguing that they were not required to warn consumers about a potential risk, if the FDA determined that the safety issue was not important enough to include in the label.

Pfizer lobbyist, Dolly Judge, said that the company was pleased with the bill, adding that she thought it would increase FDA's regulatory authority and restore confidence in the agency. The world's largest pharmaceutical company was less happy with the lawsuit changes.

Changes in the law include the following:

  • Companies which violate FDA orders on labels and studies or certain other requirements could face maximum fines of USD 250,000 for a single violation and USD 10m for multiple failings handled in one proceeding. The top fines are less than the House had previously approved.
  • The legislation includes a compromise that would place new conflict-of-interest restrictions on participants in advisory panels used by the FDA to review drugs and devices. It would require the FDA to decrease the number of participants with conflicts by five per cent a year.
  • The legislation calls on the FDA to use insurance databases, such as those maintained by insurance companies, to detect side effects suffered after medications come on the market
  • Results of clinical trials would have to be disclosed, which supporters of the legislation said would make it harder for companies to withhold results which show dangers
  • Estimated fees paid by pharmaceutical firms to the FDA would increase to USD 417.8m on 1 October 2007, compared with USD 305.5m for the current financial year. Some of the new funds will pay for drug safety, but fees will be reduced, if lawmakers increase FDA funding.
  • Companies will also pay new fees when they voluntarily submit consumer advertisements to the agency for review. The fees will allow The FDA to hire additional staff to increase reviewing speed.
  • The legislation will renew a programme which affords pharmaceutical companies an extra six months of protection from competition, if they perform FDA-requested paediatric studies. The compromise does not include a Senate provision which would have reduced the period to three months for drugs with more than USD 1bn in annual sales.

20th September 2007

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