Getting the pill over-the-counter is only part of removing barriers to contraception

Making oral contraceptive pills available without a prescription should complement, not replace policies to reduce barriers to contraceptive use, according to a new analysis by the Guttmacher Institute. Moving the pill to over-the-counter (OTC) status should be done to enhance women’s access to the full range of contraceptive methods, instead of taking its place. It is important that, while the barrier of the counter is removed, other safeguards remain in place to protect women’s access to contraception, such as ensuring insurance coverage for OTC contraceptives and not imposing medically unnecessary age restrictions.

OTC rationale

Access to birth control has long been touted as the best way to prevent unintended pregnancies. Lifting the prescription requirement for birth control pills could lower barriers to access the pill and achieve the desired results. The Guttmacher Institute noted in their analysis that U.S. women rely on the pill more than any other method. In 2012, 26 percent of contraceptive users relied on the pill; the next most commonly used methods were female sterilization (25 percent) and male condoms (15 percent). The Institute believes that “increasing access to the pill by making it available OTC could improve contraceptive use and, in turn, lower unintended pregnancy rates, especially among women who are uninsured and those who lack the time, would need to arrange for child care, or otherwise would find it difficult to visit a health care provider to obtain a prescription.”


For a formulation of a birth control pill to switch to OTC status, a pharmaceutical company would need to initiate an often lengthy and expensive process that entails research (including studies of label comprehension and consumer actual use) and review by the FDA, which can be a huge deterrent. Once put in the hands of the FDA, the agency may decide to impose an age restriction on an OTC product, which would limit access for young women. These young women, the Guttmacher Institute notes, 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 status switch. It is important they not be left out. Additionally, imposing an age requirement would then require a means of identification. This would be a disadvantage not only for adolescent and young women without government-issued photo IDs, but for immigrants as well, particularly those who are undocumented.

Packaging is also a consideration. Oregon and the District of Columbia this year enacted legislation requiring birth control pills to be packaged in one year supplies.

Comprehensive approach

The Guttmacher Institute advised that taking a comprehensive approach is best, and if policymakers truly wish to expand contraceptive access, they need find one that works for people of all ages and incomes, and covers the full range of contraceptive methods, services and care. It believes that OTC status for oral contraceptives is but one strategy to improving access that is unable to fulfill the wide range of needs of all people, especially if cost and age barriers were attached to any product.

Although the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) goes a long way towards providing contraceptive coverage, it also has limitations. Some of these could be addressed by covering more women and dropping the need to obtain a prescription for OTC coverage. According to the Guttmacher Institute, what the ACA began in terms of contraception coverage policy should be only strengthened by providing OTC birth control pills. An OTC designation for birth control should not replace the contraception coverage requirements if public policy is truly meant to provide women with coverage options that are best for them.

American Medical Association calling for an end to direct-to-consumer drug advertising

The American Medical Association (AMA) has taken an interesting policy stance in an effort to promote affordable treatment options. In an interim meeting held November 17, 2015, the AMA voted to support a ban on direct consumer advertising of drugs and medical devices. The physicians believe that these advertisements are causing patients to push for more expensive treatments while cheaper, effective alternatives are available.

Consumer advertising

The U.S. is one of two countries in the world that permits direct consumer advertising of drugs, the other being New Zealand. According to the World Health Organization (WHO),  the practice became much more popular in 1997 after the FDA loosened the requirement for manufacturers to provide a list of side-effects in infomercials. Companies attempted to push for more advertising opportunities in Europe, but the European Union countries strongly opposed the section of new legislation that would allow companies to provide more information directly to patients through the internet and specialist publications.

A study published in 2003 compared prescribing decisions in the U.S. with decisions in Canada and how those decisions were impacted by consumer advertising. Patients were surveyed before primary care appointments on how much advertising they had been exposed to, while physicians were surveyed after their appointments to find out how many patients requested an advertised medicine and how many prescriptions were written in response to patient request. The survey also asked physicians to measure their confidence in the treatment choice and whether the physician would have prescribed the same drug to another patient with the same diagnosis. The study’s results indicated that those exposed to more advertising are more likely to request those medications, which leads to more prescriptions written even if the physicians are not confident about the treatment.

A long debate

Despite the fact that advertisements are overseen by the FDA for truth and accuracy, the practice has been debated for years.  In 2008, Time approached the topic after it received some scrutiny in a House of Representatives hearing. The article stated that drug ads often leave viewers confused about the information that they saw. This assertion was supported with notes from a New England Journal of Medicine article that pointed out the ease with which a medical device advertisement glossed over information that is still being debated by specialists. Time analyzed how ads are created, with an emphasis on the drug’s benefits at the beginning and end of a commercial when they are more likely to be remembered with side effect information squeezed in the middle. Ads often speed up the voice over when listing side effects, which caused viewers to be less likely to remember them when tested than for ads that maintained a constant voice over speed.

Why the opposition?

The AMA believes that skyrocketing drug prices are affecting physicians’ ability to properly care for patients, such as when there are limitations on their health insurance plans or out-of-pocket prices are unaffordable. The association points to marketing as one of the reasons for the increase in prices, with pharmaceutical companies spending billions of dollars to advertise their drugs in hopes that patients will request them specifically. The new policy urges federal limitations on anticompetitive behavior among pharmaceutical companies that try to sway business away from generic manufacturers, as well as patent reform. The AMA believes that transparency of prescription drug pricing will benefit patients and physicians.

Fast-tracked heroin antidote approval puts opioid epidemic on route to recovery

Narcan® nasal spray, a nasal spray version of naloxone hydrochloride, a life-saving medication that can either stop or reverse the effects of an opioid overdose, is now approved by the FDA. Until now, naloxone was only approved in injectable forms, which are most commonly delivered via syringe or auto-injector. The FDA approved the nasal spray to make the delivery of the medication a safer process and eliminate the potential risk of a contaminated needle stick.

“Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, M.D., acting commissioner of the FDA. “We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”

Combatting abuse

The FDA’s move to approve Narcan nasal spray is meant to provide help to a fast spreading epidemic of opioid abuse. Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin. Drug overdose deaths, driven largely by prescription drug overdoses such as opioids, are now the leading cause of injury death in the United States—surpassing motor vehicle crashes, according to the FDA.

The Narcan nasal spray will be easier to use, as it can be administered by anyone, even individuals without any medical training. Narcan nasal spray does not require assembly and delivers a consistent, measured dose when used as directed.

Fast track

One way the government is combatting the statistic is by approving drugs like Narcan, which, if administered quickly, can counter opioid overdose effects, usually within two minutes. The FDA granted fast-track designation and priority review for Narcan nasal spray earlier in 2015. Fast track is a process designed to facilitate development and expedite review of drugs intended to treat serious conditions and that demonstrate the potential to address an unmet medical need. Narcan nasal spray approval took place in less than four months, which is significantly faster than the product’s prescription drug user fee goal date of January 20, 2016.

“We heard the public call for this new route of administration, and we are happy to have been able to move so quickly on a product we are confident will deliver consistently adequate levels of the medication—a critical attribute for this emergency life-saving drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Seems like smooth sailing for Califf’s FDA nomination

Dr. Robert Califf, President Obama’s nominee to be the Commissioner of the Food and Drug Administration (FDA), coasted through questions at a confirmation hearing Tuesday in front of the Senate Health, Education, Labor and Pensions (HELP) Committee. Although many thought the process may hit a few bumps due to his ties with the pharmaceutical industry, Republicans and Democrats alike seem to support his candidacy and the nomination seems expected.

Califf’s background

A cardiologist and clinical trial expert from Duke University, Dr. Califf has been a consultant to drug companies and ran a research institute that received a majority of its funding from the industry. Dr. Califf said in his prepared statement that we need “an unbiased FDA that can work with industry to advance critical technologies while still making independent determinations to ensure that scientific potential is translated into safe and effective products. To advance, we must find common ground with industry and academia on the science without compromising this fundamental role of the FDA.”

Califf’s ties to the industry raised concerns among some public health groups and some Democrats say that he is too close to the industry he is being called on to regulate. Many medical experts dispute that, saying that industry is a principal funder of research in the United States and that working with companies does not present an inherent conflict.

Although essentially friendly, the hearing was punctuated with a few skeptical questions from Senators Elizabeth Warren (D-Mass) and Bernie Sanders (I-VT), who is running for the Democratic presidential nomination. In response to questions from Warren, Califf told the committee that the clinical trials he conducted at Duke, if funded by a drug company, had “ironclad” contracts giving the investigators the final rights to publication. Sanders said aid that the FDA needs a candidate who can stand up to an industry that has been “ripping off” the American people by charging “outrageous” prices for medicines.


The HELP committee will vote on whether to approve Califf’s nomination, which must then be approved by the full Senate. Patient groups and medical associations are hoping that Califf will help to speed new drugs to market and have publicly supported Califf.