Leaders Weigh in on how the Fall of Roe Will Affect Biopharma

 The U.S. Supreme Court’s decision to overturn Roe v. Wade has had a ripple effect on the biopharmaceutical industry. As the nation reacts, pharma companies must address the changes in demand for reproductive health drugs and services, all while navigating increasingly muddy legal waters. 

The reversal of Roe v. Wade primarily affects the pharma industry in two ways. The first, and most obvious, is the effect it will have on companies that manufacture mifepristone and misoprostol, more commonly known as the abortion pill. The second is the rise in demand for contraceptives following the SCOTUS decision. 

Medication Abortion—an Ongoing Battle

The abortion pill is actually two different pills prescribed together– first, the patient takes mifepristone, which blocks the production of progesterone and keeps the pregnancy from advancing. The patient then takes misoprostol, which causes the uterus to contract and expel anything inside.  

Medication abortions currently account for over half of all abortions in the United States, according to a study by the Guttmacher Institute published in February. Mifeprex became the first abortion pill approved by the U.S. Food and Drug Administration in 2000. And in 2019, the FDA approved a generic version of the drug.  

Unsurprisingly, medication abortions have been at the center of controversy and legal battles for years. When Mifeprex was first approved by the FDA, it could only be prescribed and dispensed in person at a hospital, clinic or doctor’s office. But when the COVID-19 pandemic hit, the American Civil Liberties Union, along with several other reproductive rights groups, sued the Trump administration and requested an emergency order to lift those regulations and allow the drug to be prescribed virtually.  

A judge granted the request, but the Supreme Court reinstated the in-person restriction after protests from the Trump administration. This back-and-forth finally came to an end in December, when the FDA permanently lifted the requirement, allowing patients to use telehealth services to get virtual prescriptions and receive them by mail.  

Now that abortion laws are regulated by the states, the FDA’s decision has called the legality of telehealth for abortion into question. Though the abortion pill is still available by mail, a patient living in a state where abortion is banned must travel to a state where it’s legal to be prescribed the medication, even if their appointment is virtual.  

Still, the Supreme Court’s decision will likely result in pharma companies that manufacture abortion pills racing to keep up with heightened demand. For almost 20 years, Danco Laboratories was the sole manufacturer of Mifeprex. But in 2019, GenBioPro’s generic version of the drug was approved by the FDA. Corcept Therapeutics is the only other FDA-approved manufacturer of the drug, but it contains a much higher dose and can only be used as a treatment for Cushing’s Syndrome.  

A spokesperson from Danco Laboratories told ABC News that Danco is prepared for any changes in demand and that it is working with federal regulators to make the drug available in pharmacies “by the end of the year.”  

"We are prepared for any surge,” the spokesperson said. “Our supply is stable and plentiful." 

A Scramble for Contraceptives

The Roe v. Wade case involved only abortions, but a decrease in access to abortion has led to a surge in demand for contraceptives, particularly emergency contraception.  

On Tuesday, CBS News reported that Wisp, an online reproductive and sexual health provider, saw a staggering 3000% increase in sales of emergency contraceptive pills following the Supreme Court’s decision. Surprisingly, Wisp CEO Ahmad Bani told CBS that so far, the company has been able to keep up with demand.  

This might be due to the time the company had to prepare, as Wisp saw a 40% increase in sales of emergency contraceptives after the draft of the SCOTUS decision was leaked in May. 

Other pharmacies are taking precautionary measures to prevent a shortage of emergency contraception. CVS said that though it has an “ample supply” of emergency contraceptives in stock, customers are limited to purchasing up to three boxes per transaction. Rite Aid followed suit, citing “increased demand” as the cause.  

For online ordering, supply is limited. Most emergency contraceptives on Amazon are not available for delivery until mid-July, and Walgreens has paused its online delivery service for contraceptives, according to The New York Times.  

Accessibility of Emergency Contraceptives– Or Lack Thereof

The most well-known emergency contraceptive is Plan B. First approved by the FDA in 1999, Plan B and its generic versions use the active ingredient levonorgestrel (LNG) to prevent pregnancy after unprotected sex. Plan B can be bought over the counter at pharmacies and retailers across the U.S. 

Though Plan B is effective, it loses its efficacy for people over 165 lbs, as well as for those who wait longer than three days after intercourse to take it. For those patients, the best alternative is ulipristal acetate, sold under the brand name ella. The drug is effective for up to five days after unprotected sex.  

But actually attaining ella is more difficult. It’s a prescription drug, so anyone who needs it must make an appointment with a physician for a prescription. After that, the next challenge is finding a pharmacy that has ella in stock.  

Dr. Sonya Borrero, a professor of medicine at the University of Pittsburgh who focuses on reproductive health equity, told NPR that she sent a team of medical students across western Pennsylvania to find out which contraceptives pharmacies keep in stock. She found that only 5% of the pharmacies they visited had ella available for immediate purchase.  

Rebecca Stone, Pharm.D., clinical associate professor at the University of Georgia School of Pharmacy and a practicing pharmacist, conducted a similar study published in December. Of the 600 pharmacies across Georgia included in the study, less than 1% had ella in stock.  

“It tends to not be readily available,” Stone said in an interview with BioSpace. “Most pharmacies will order it to be delivered the next day, but it’s more effective the sooner you take it.”  

And for those who are prescribed ella after they miss the time window for Plan B, that extra 24 hours could be too long to wait.  

Stone said she expects pharmaceutical companies to increase production to keep up with demand. But in the meantime, she urged anyone who is sexually active to use a reliable form of contraception and have emergency contraceptives on hand, just in case.  

As for the pharma industry, Stone said that while she can’t see the future, she expects some changes to be made. One of those includes a change that, on the surface, seems trivial – packaging.  

Plan B and its generics work by preventing ovulation. But the packaging for Plan B reads that it “may prevent implantation.” The label hasn’t changed since the FDA first approved the drug in 1999, though that statement has since been proven false. The packaging has already been changed in Europe to omit this statement, but the U.S. has yet to follow suit.  

“Religious groups and groups who are opposed to emergency contraception access cite [the label] as a reason for why emergency contraceptives shouldn't be available because they consider it to be more like an abortifacient,” Stone said. “But that's not supported in medicine.” 

This difference is key in understanding how emergency contraceptives work, especially as the Supreme Court’s decision has spurred debate about reproductive health services. Stone added that she and her colleagues in pharma are “trying hard to help pharmaceutical companies that manufacture this product update the packaging to reflect the current science.”  

As the nation reacts to the Roe decision, many pharma companies have benefitted from the increased demand for contraceptives. Still, the industry shouldn’t get too comfortable. As the discussion moves from abortion to contraceptives and reproductive health measures in general, these most recent changes could be only the tip of the iceberg. 

As Katie Watson, a constitutional scholar and medical ethicist at the Feinberg School of Medicine at Northwestern University told The New York Times, the pharmaceutical industry is currently in uncharted territory.  

“When people say we’re going back to the days before Roe, there’s no such thing as a time machine – we have a very different pharmaceutical landscape.” 

https://www.biospace.com/article/leaders-weigh-in-on-how-the-fall-of-roe-will-affect-biopharma-/