Panel urges more birth control studies
WASHINGTON – Government advisers on Wednesday recommended against setting specific requirements for the reliability of new hormonal contraceptives, saying that might keep useful approaches 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 that failed to show up during initial testing.
The recommendations came a day after the panel recommended 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 that the agency require drug makers to test any new approaches on smokers, teenagers, women over age 35 and others to get a more realistic 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, the 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 procedures had been reviewed.
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, new methods are being developed, and the types of women using the approaches has changed, including more overweight women – for whom lower doses might be inadequate.
“We think the studies should better reflect the real world,” said Charles Lockwood, of Yale University, who chaired the panel.
Wednesday, the panel said the effectiveness of each method should be judged individually, weighing it against the potential 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 recommendation 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, who also endorsed the recommendations to test products on more representative samples.
Lockwood said the panel did not want to discourage drug companies from developing new methods by requiring them to always conduct expensive follow-up studies. Instead, it called for follow-up studies only when necessary for a specific reason, such as a new delivery method or a new type of hormone.