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New Bill Would Speed FDA Review of OTC Contraceptives

Posted 10 May 2016 | By Michael Mezher 

New Bill Would Speed FDA Review of OTC Contraceptives

Editor's note: This article has been updated to clarify that the Oregon bill allows pharmacists to prescribe certain contraceptive drugs to patients.

A new House bill, sponsored by Rep. Mia Love (R-UT), would speed the review of contraceptive drugs by the US Food and Drug Administration (FDA), and includes measures to make the drugs available over-the-counter for adult women.

The bill, known as the Over-The-Counter Contraceptives Act, would compel FDA to grant supplemental applications for contraceptive drugs a six-month priority review, and if approved, make them available without a prescription to women 18 and older.

Recently, state legislatures in California, Washington and Maryland passed bills allowing certain contraceptive drugs to be sold over-the-counter, and in Oregon, a law allowing pharmacists to prescribe self-administered hormonal contraceptives to patients without a prescription from a doctor. Other states, such as Hawaii, Missouri, New Jersey, Tennessee and South Carolina are also considering similar measures.

However, if passed, the Over-The-Counter Contraceptives Act would go beyond state measures by speeding the approval of new contraceptive drugs in addition to making these drugs available over-the-counter.

In addition to the priority review and over-the-counter provisions, the bill would also repeal section 9003 of the Affordable Care Act (ACA), which requires patients to have a prescription in order to be reimbursed for over-the-counter drugs through flexible spending arrangements (FSA) and health reimbursement arrangements (HSA). Additionally, the bill would remove the $2,500 per year limit on employer contributions to HSAs from the ACA.

Over-the-Counter Contraception and Criticisms

Barring certain religious institutions, employer insurance plans are required to cover prescription female contraceptives under the ACA.

However, some groups, such as the Guttmacher Institute, a research policy organization focused on reproductive health, have argued that requiring prescriptions for contraceptives is a barrier to access for many women.

"Although it would be insufficient as a stand-alone strategy to ensure contraceptive access, [over-the-counter contraception] would be an important component of a multifaceted strategy to preserve and enhance access to the wide range of contraceptive methods that people need throughout their reproductive lives," the group wrote in a policy paper last fall.

In the paper, Guttmacher also claims that conservatives may be pushing efforts such as the Over-The-Counter Contraceptives Act as a "strategy to deflect allegations that they were waging a 'war on women.'"

The paper also cites fears that conservatives would push for age restrictions, such as the one in the new bill, as a means of restricting access.

"Many experts fear that in response to conservative demands, the FDA or other policymakers might impose an age restriction on an [over-the-counter] product, which would limit access for adolescent and young women. These age-groups face a greater risk of unintended pregnancy and more barriers to accessing contraceptives than older women—and therefore have the most to gain from an OTC switch," the group wrote.

Over-The-Counter Contraceptivves Act of 2016


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