by Steven Ertelt
February 15, 2005
Washington, DC (LifeNews.com) — One day after President Bush announced the appointment of acting Food and Drug Administration director Lester Crawford to head the agency, the FDA says it will create a new panel to oversee safety issues associated with any drugs it approves.
The new independent Drug Safety Oversight Board will monitor any approved medicines once they’re approved for the market, such as the abortion drug RU 496 and the so-called morning after pills.
The agency will update both physicians and patients with updated information on risks and benefits of drugs as they become available.
Health and Human Services Secretary Mike Leavitt announced the creation of the board following a Tuesday meeting with FDA employees.
"They want to know what we know, what we do with information and why we do it," Leavitt said of patients and doctors. He promised to create "a new culture of openness and enhanced independence."
Pro-life groups want the RU 486 mifepristone pill pulled form the market while its safety is examined and they don’t want the morning after drug to be approved for over the counter sales.
Last year the FDA strengthened its black box warning labels on the RU 486 drug, making them the most severe the agency issues. The abortion pills have been responsible for the deaths of three women.
The board will suggest information to be put on the agency’s Drug Watch safety list, help resolve disputes over drug safety information and oversee the development of a safety policy.
The panel will consist of FDA employees, medical experts from other HHS agencies and departments, and will consult with outside experts and doctor and patient groups.
The new panel will use one-page factsheets and a web site to keep people updated.
Last month, the FDA delayed its decision on whether to allow sales of the so-called morning after pill over the counter. The federal agency was expected to reach a decision Friday but said in a statement that it needed more time to review the drug.
The FDA rejected a proposal by Barr Pharmaceuticals last year to allow the drug, which sometimes causes abortions, to be sold to anyone without a doctor’s visit.
Agency officials said Barr did not provide enough information on how the drug affects teenagers.
Barr submitted a new application asking that the drug, also known as Plan B, be sold without a prescription only to those above 16 years of age.
FDA Announcement – https://press.arrivenet.com/gov/article.php/589015.html