The agency discussed at a hearing yesterday whether cholesterol, asthma, migraine and blood-pressure medications should be sold over-the-counter, a regulatory change intended to lower costs and ease access to drugs for people with chronic ailments. Reproductive-rights advocates today urged that any expansion of nonprescription drugs include birth control.
Amid an election campaign that has at times focused on women’s health, and fewer than four months after the Obama administration overrode the FDA’s support for expanding nonprescription sales of morning-after pills, the hearing was another front in the debate over birth control. Women can determine whether they should use oral contraceptives, and may be better off not seeing a physician, said Eleanor Schwarz, an associate professor of medicine at the University of Pittsburgh, in a telephone interview.
“It has been a politically charged topic,” said Schwarz, who addressed the FDA. “When we keep it within the purely health-and-science realm, we understand it saves people’s lives. All available contraceptives are much safer for women’s health than an undesired pregnancy.”
Republican presidential candidates, including Mitt Romney and Rick Santorum, have attacked U.S. President Barack Obama’s 2010 health-care law for violating religious freedom by requiring most employers to provide contraceptive coverage. More than six in 10 respondents to a Bloomberg National Poll — including almost 70 percent of women — say the issue is a matter of health care and access to birth control rather than religious liberty, according to the survey taken March 8-11.
The FDA began its two-day public hearing yesterday to discuss way to enhance pharmacists’ roles in chronic treatments or supplement drug labels in an interactive way that helps people determine whether they have a condition and need a drug, said Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research. The agency hasn’t taken a position on oral contraception.
In December, U.S. Secretary of Health and Human Services Kathleen Sebelius blocked the FDA’s decision to approve Teva Pharmaceutical Industries Ltd. (TEVA)’s Plan B One-Step as the first unrestricted over-the-counter emergency contraceptive. Sebelius stepped in and ordered FDA Commissioner Margaret Hamburg to reject Teva’s application to make the drug available to girls younger than 17 without a prescription.
Sebelius’s intervention was the first time HHS overrode an FDA staff decision.
With this week’s meeting, the FDA is seeking ways to increase medication access and reduce the number of routine doctor visits, the agency said last month in a statement. It cited four examples of drugs that may make good over-the-counter candidates — cholesterol, asthma, migraine and blood-pressure treatments.
Over-the-counter medicines save the U.S. health-care system $102 billion a year, according to the Consumer Healthcare Products Association, the nonprescription drugmakers’ lobbying group in Washington.
Consumers may see their costs go up because insurance plans typically cover only prescription drugs, said Daniel Grossman, a senior associate at Ibis Reproductive Health, a research and advocacy group based in Cambridge, Massachusetts, in a telephone interview.
While increased cost is a concern, women still need better access to contraception, said Grossman, who is also appeared at the FDA hearing.
“It would be very simple to use technology for a woman to determine if this pill was appropriate for her,” Grossman said yesterday in an interview.
Schwarz led a team at the University of Pittsburgh that created a computer kiosk to help women determine if they should take birth-control pills or whether they smoked, had migraines with an aura or other conditions that may make taking the pills inadvisable.
“It’s women who determine if they are at risk of unintended pregnancy,” Grossman told the FDA panel today.
While not a statistically significant difference, researchers found 75 percent of women in a clinical trial who had been to the doctor and used the kiosk for refills had a condition that made taking the pills questionable and 52 percent attempting to get the pills for the first time possibly shouldn’t.
“This program identifies women who can safely use hormonal contraception as well, or better than, most doctors,” Schwarz said.
Grossman said he isn’t aware of a drugmaker that wants to switch its birth-control pills to nonprescription status.
Johnson & Johnson (JNJ)’s McNeil Consumer Healthcare division has experience marketing formerly prescription-only products, including Nicorette, Motrin and Pepcid. The unit makes Ortho Micronor, an oral contraceptive that uses only the hormone progestin, which is known to have fewer contraindications than combination hormone pills.
Mark Wolfe, a spokesman for New Brunswick, New Jersey-based J&J, said the company doesn’t comment on speculation.
Drugmakers must apply to the FDA after clinical trials on nonprescription use to switch their products to over-the-counter status.
The American Medical Association, based in Chicago, opposes the move to more over-the-counter drugs, arguing at the panel yesterday that patient adherence to a medication regimen depends on physicians.
“Lack of oversight from a practitioner could be a serious concern,” said Sandra Adamson Fryhofer, chairwoman-elect of the association’s science and public health council.