Trump administration distorting science on safety of FDA-approved contraception, former FDA officials tell Appeals Court

Amicus brief from Drs. Hamburg, Ostroff, and Lurie support Pennsylvania and New Jersey’s efforts to preserve insurance coverage for contraceptives

Three former Food and Drug Administration officials say the Trump administration distorted the science on the safety of FDA-approved contraceptives when it published final rules expanding religious or moral exemptions for employers who want to deny their employees no-cost contraceptive coverage as provided for in the Affordable Care Act.

In an Amicus brief filed with the U.S. Court of Appeals for the Third Circuit in Philadelphia, former FDA Commissioner Dr. Margaret Hamburg, former Acting FDA Commissioner Dr. Stephen Ostroff, and former FDA Associate Commissioner Dr. Peter G. Lurie, currently president of the Center for Science in the Public Interest, argue that those final rules manufactured unwarranted “uncertainty” about the products’ effectiveness and impact on women’s health, and ignored the FDA’s track record when it comes to ensuring the safety and efficacy of drugs and medical devices. The physicians are represented by CSPI’s litigation department.

The brief is filed in support of Pennsylvania and New Jersey, which are challenging the final rules promulgated by the Trump administration. The states argue that the rules run afoul of the Administrative Procedure Act because they fail to provide a sufficiently reasoned explanation for the change in policy. The long-running litigation originally springs from requirements in the Affordable Care Act that require employers to provide health coverage for certain preventive services. A religious order, Little Sisters of the Poor, argued against providing such coverage for its employees.

The former FDA officials argue in their brief that the FDA’s premarket evaluation and continuing post-market monitoring create one of the world’s most stringent regulatory systems, and that the safety of contraceptives has been monitored for years, or in some cases, decades. And, they write, the administration cherry-picked and misrepresented data on the risks and benefits of both contraception and pregnancy, conflated hormonal and non-hormonal contraceptive products, and discounted the FDA’s existing labeling of contraceptives’ side-effects when it issued its final rules. 

“Defendants have failed to provide a sufficiently reasoned explanation for asserting purported ‘uncertainty’ as to the safety, effectiveness and benefits of Covered Contraceptives, or for changing their position on this issue; rather, as FDA has made clear by granting and maintaining approval for these products, they are safe and effective methods for pregnancy prevention when used as labeled,” the former FDA officials wrote in the brief.

Before the issuance of the final rules at issue, the Health Resources and Services Administration’s guidelines required employer-based health plans to cover 17 different forms of FDA-approved contraceptives at no cost to the plan participant.

“FDA requires years of clinical trials demonstrating safety and efficacy before drugs or medical devices reach the public, a requirement to which the drugs and devices at issue were subject,” said Dr. Lurie. “It’s unreasonable for the government to now cast doubt on an entire category of medicine that has a well-documented history of preventing unintended pregnancy and providing clear health benefits and that it had itself approved.”

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