Author: Courtney Thomas

Zulresso: The First and Only Drug Approved to Treat Postpartum Depression

In March, the FDA finally approved Sage Therapeutics’ drug Zulresso (brexanolone) as the first drug intended to treat postpartum depression (PPD) in adult women. Before Zulresso, the only drug used to treat PPD was anti-depressants. Compared to anti-depressants, which could take weeks to regulate PPD symptoms, Zulresso improves symptoms within days. The approval of Zulresso marks a crucial milestone for women who have long suffered from PPD.

Having a baby is supposed to be a joyous occasion, however, within days, or even hours, many women feel depressed. Some women experience the less severe form of the “baby blues” while others suffer from severe and life-threatening PPD. PPD is a major form of depression that occurs in about 1 in 9 women after childbirth. PPD symptoms vary but often include feelings of extreme sadness, anxiety, suicidal thoughts, and severe doubts about the mothers ability to care for her baby. All women are susceptible to PPD because PPD does not manifest itself in one “type” of person, i.e. specific race, culture, etc. Some experts believe that PPD is more prevalent than reported because not all women talk about or seek treatment for PPD. Zulresso is the first drug to provide hope to the millions of women who suffer from this disorder. 

Yet, although Zulresso seems like a saving grace, it is still a drug that comes with serious risks. The FDA reported that serious risks, like excessive sedation or sudden loss of consciousness, occurred after taking Zulresso. Because of these risks, Zulresso was approved with a Risk Evaluation and Mitigation Strategy (REMS). A REMS program helps ensure FDA that the benefits of the drug outweigh its risk and that patients taking the drug are safe. In Zulresso’s case, the REMS program makes Zulresso available only through an intravenous (IV) injection that must be administered and monitored by a health care provider. Since Zulresso takes a total of 60 hours to administer,the REMS program requires patients to be continually monitored the entire administration period. In addition, all patients must be registered and complete counseling before taking Zulresso. 

However, a drug this powerful won’t come cheap. A one-time infusion of Zulresso is expected to cost $34,000 before discounts. For many women without insurance, Zulresso may be unattainable. However, since Zulresso has been clinically proven to be effective for PPD, many women will find its price worth it. Even Sage’s chief executive officer, Jeff Jones, acknowledged the high price of Zulresso, and said that “Zulresso’s medical benefits will overcome any concerns about cost and delivery.” 

Zulresso is expected to launch in late June, and Sage Therapeutics is already working on creating centers for women to have access to the drug. Although the nation is excited about Zulresso, Sage Therapeutics is already working on another fast-acting antidepressant pill that could treat postpartum depression too. However, Zulresso and Sage Therapeutics might have some competition from Marinus, a company also developing and testing a drug to treat PPD. Competition or not, the approval of Zulresso means that fewer women have to suffer and many more women can enjoy motherhood.  

Cosmetic Regulation in the U.S.: Is the FDA doing enough?

The Food and Drug Administration (FDA) has had authority over cosmetics since the passing of the Food, Drug, and Cosmetic Act (FDCA) in 1938. However, this authority is based only in regulatory power, not approval power. The FDCA does not require cosmetics to acquire pre-market approval, except for cosmetics that have color additives like medical devices and drugs; instead, the FDA uses post-market regulation to bring formal or informal proceedings against a product.The FDA’s authority over the cosmetic industry, which generated approximately $84 billion in revenue in 2016, is substantially different than any other industry area the Agency regulates. 

The FDCA defines cosmetics as any product that is “intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.” This includes the obvious, such as moisturizers and facial makeup, but also the nonobvious, such as deodorant and permanent hair waves.  Under this definition, the category of cosmetics encompasses things that both women and men use on a daily basis.  

So how does FDA regulate cosmetics? The FDCA prohibits the marketing of cosmetics that have been adulterated or misbranded. Adulteration address violations involving product composition whereas misbranding addresses improperly labeled or deceptively packaged products. However, the main issue with cosmetics is safety. The FDA states that “companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products,” however “[no] FDA regulation require specific tests to demonstrate the safety of individual products or ingredients.” Companies can use “whatever testing necessary” to guarantee safety. Companies can rely upon already available test data on individual ingredients and similar product formulations or perform their own test for additional information. Even if companies conduct thorough safety testing, “the law also does not require cosmetic companies to share their safety information with FDA.” 

An optimistic approach to FDA regulation would require consumers to fully believe that cosmetic companies conduct thorough safety testing. Since a company’s reputation is on the line, testing for safety is, or should be, a company’s top priority. That is why some dermatologists believe that cosmetics are already safe and that more regulation would be unnecessary. Some also argue that stricter regulation could stifle innovation. Every year there is a new ingredient craze that rocks the cosmetic world.  With stricter regulations, these new ingredients would have to pass through extensive testing which could disincentivize innovation, lead to poorer products, and potentially increase costs. 

Since the industry self-polices, the FDA has to rely on direct reports and complaints from consumers before it can act. For example, in 2014 the FDA launched an investigation into Wen Hair Care after it received about 1,400 complaints about adverse side effects of the hair care products, like hair loss and balding. During its investigation, the FDA learned that Wen Hair Care actually received over 20,000 complaints from consumers before FDA was alerted. Under the FDCA, the FDA could only go after the Wen Hair Care if the products were determined to be adulterated or misbranded. However, if adulterations or misbranding is not the issue, then what can the FDA do? Short of seizing the products to keep them off the market, nothing. 

Current cosmetic regulation might be changing in the near future, though. There are more and more consumers that are looking for health-conscious and clean cosmetic products. Congress has also made a push toward increasing cosmetic safety. In 2017, Senators Dianne Feinstein and Susan Collins introduced a bipartisan proposal that included mandatory reporting and ingredient review of all cosmetics. Also, in 2018, Congresswoman Jan Schakowsky introduced a bill that “…calls for the full disclosure of all ingredients included in beauty and personal care products including fragrances.” While these bills are stirring around in Congress, major cosmetic brands like L’Oréal and Unilever, as well as celebrities like Kourtney Kardashian offer their support for stronger regulation.

 In 2018, Rep.Frank Pallone stated that “[w]hile all other product categories regulated by the [FDA] have been updated to keep pace with innovation and consumer expectations, the laws for cosmetics have been left untouched for nearly 80 years.” Maybe it is time for a change.  

The Bleeding Edge and the Unsettling Truth About Medical Devices Today

After its premiere on Netflix, the documentary, The Bleeding Edge,immediately received attention for its critical look inside the billion-dollar medical device industry in the United States. In the documentary, men and women across the country openly discussed how their lives were affected after they used FDA approved medical devices. Most of the critics in the film focused on Bayer’s Essure sterilization device and Johnson & Johnson’s vaginal mesh, while also shedding light on artificial metal hip replacements and Intuitive’s Surgical da Vinci robotic arm. The documentary’s investigation into the FDA’s regulatory process of medical devices shows that more often than not medical devices get on the market without proper testing.

The FDA conducts its regulation pursuant to the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Act, which established three regulatory classes for medical devices. Several of the devices the documentary discussed are Class III devices, which “usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.” Class III devices are subject to a pre-market approval process where companies must produce research that proves that the new device is safe and effective. Bayer’s Essure, Johnson & Johnson’s vaginal mesh, and artificial metal hips are considered implants, under the Class III definition, but most of these were not subject to this process.

Bayer’s and Johnson & Johnson’s devices made their way through the 510(k) certification, which was created for Class II devices that are less risky to patients. This certification process allows the FDA to certify a company’s new medical device based on evidence that it is “substantially equivalent” to another device already on the market. To be clear, this is not an approval process, instead, this is a clearance process that allows new medical devices to enter the market without requiring device testing.  This process is, in essence, a “loophole” and allows devices to hit the market at a faster rate. Most medical devices are now regulated under this loophole instead of the pre-market approval process.

A serious question still remains: Can we trust that devices are safe and effective when they are cleared but not approved through this certification process? The patients in The Bleeding Edgesay no, yet Bayer and many other companies say yes. Days after the documentary premiered on Netflix, Bayer hit the media calling the allegations in the documentary “inaccurate and [a] misleading picture of Essure” and described the documentary as an “anecdote” created to fit an agenda.

Patients continue to seek better regulation even if the medical device industry and the FDA seem to be unbothered by the film and defend their regulation. However, even before the film aired, Johnson & Johnson and Bayer faced several class action suits due to their products. Specifically, about 16,000 women have sued Bayer in a class action suit. This prompted the FDA to issue a warning to Bayer and ordered the company to conduct risk assessment studies, which in hindsight should have been required. Bayer will now take Essure off the market by the end of this year. This is good news for those affected by this device, but it is not the only one out there causing life-threatening problems.

The FDA has yet to try to bridge the gap in their current regulation of medical devices, but many supporters of the film hope it will encourage movement toward more thorough regulation and safety of medical devices. As technology and innovation continue to advance, regulating medical devices will only get worse unless the FDA closes the holes in its regulatory process and puts patient safety first.