FDA Panel Supports Flexibility in the Approval of Hormonal Contraceptives
Thursday, January 25, 2007
Government advisers yesterday recommended against setting specific requirements for the reliability of new hormonal contraceptives, saying that might keep useful products off the market.
The panel did recommend, however, that the Food and Drug Administration ask drug companies to conduct follow-up studies on some new methods after they go on the market to identify any safety or reliability problems missed during initial testing.
The recommendations came a day after the panel called for testing new hormonal contraceptives on women who are more representative of the general population, including, for example, women who are overweight. The panel also urged the agency to require drugmakers to test new approaches on smokers, teenagers, women older than 35, and others to get a better assessment of their effectiveness and risks.
The agency is not required to follow the panel's advice, but an FDA official said it probably would.
"This was very useful," said Scott Monroe, acting director of the FDA's division of reproductive and urologic products. "All the recommendations are recommendations we are likely to implement."
The FDA convened the panel for a two-day meeting to advise the agency on what criteria should be used to decide when to test new hormonal contraceptives, including pills and patches, because it has been more than a decade since the last review.
In that time, a number of changes have occurred. The dosages of hormones in some contraceptives have been lowered to reduce the risk of side effects, and new methods are being developed. Even the user has changed: There are more overweight women, and the lower doses may not work for them.
"We think the studies should better reflect the real world," said Yale University's Charles J. Lockwood, who chaired the panel.
Yesterday, the panel said the effectiveness of each method should be judged individually and weighed against the benefits.
"You might have a product that has a higher failure rate but has all kinds of benefits," Lockwood said. "We were uncomfortable being pinned down to a specific number."
That approach was endorsed by some women's health advocates.
"We think an individual woman might choose a product that's less effective because it has some other quality that she likes, such as fewer side effects," said Amy Allina of the National Women's Health Network. She also endorsed the recommendation to test products on more representative groups of women.
"Given the trends in weight in the population, we're talking about a significant proportion of women in the United States," Allina said.
Lockwood said the panel did not want to discourage drug companies from developing new methods by making expensive follow-up studies mandatory. Instead, it recommended follow-up studies only for specific reasons, such as a new delivery method or a new type of hormone.