Source Pravda.Ru

FDA tries to ensure patients' safety

The Food and Drug Administration's system of rapidly approving new drugs fails to ensure patient safety because &to=http:// english.pravda.ru/mailbox/22/98/396/14283_usa.html ' target=_blank>drug companies are not doing the required follow-up studies and the agency has not cracked down, a U.S. congressman said on Wednesday.

Under the FDA's accelerated approval process, pharmaceutical companies wanting to manufacture drugs for life-threatening conditions can provide the government with less information about the drug's safety and efficacy than is usually required.

In exchange, the companies are supposed to conduct follow-up studies to prove the drug benefits patients. The FDA can withdraw accelerated approval if research fails to show the expected improvement, informs Reuters Alert.

Allergan Inc. said Wednesday that after reviewing multiple options presented by the &to=http:// english.pravda.ru/main/18/90/360/13642_contacts.html ' target=_blank>Food and Drug Administration, the company plans to conduct another study of its psoriasis treatment in an attempt to gain approval for the drug, which was rejected last fall.

The company, best-known for its Botox wrinkle treatment, said that in a recent letter the FDA outlined potential ways that Allergan could improve the risk-benefit profile of its oral tazarotene drug.