Editor's note: After this piece was published, a federal appeals court ruled that Mifepristone can remain on the market, but with temporary restrictions. The legal landscape surrounding this case will continue to evolve.
This past Friday, two opposing federal court decisions led to what is possibly the most disputed and disorderly legal battle over abortion access since last summer's Supreme Court verdict that reversed Roe v. Wade and ended the nationwide right to abortion.
In one instance, a Texas judge suspended the FDA's 2000 authorization of mifepristone (Mifeprex), used as part of a two-drug combination to end a pregnancy at up to 70 days of gestation. The judge went further, challenging the FDA and its autonomous safety review and approval of drugs. Shortly after, another court in Washington state issued a much different opinion. It said the FDA could not do anything to reduce the availability of the abortion medication.
The U.S. Department of Justice has appealed the Texas ruling.
The majority (79%) of abortions occur of gestation and of all U.S. abortions are medication abortions. The implications of the Texas ruling are clear: banning the drug will result in fewer abortion options, requiring surgical abortions, black-market drug sales, unwanted pregnancies, or less safe or abortion options.
But the Texas ruling will affect the availability of other drugs too -- with significant implications for the business of healthcare.
The Role of FDA
The main function of the FDA is to ensure the safety of food and drugs. Without it, payers will not cover costs, Americans will not trust medications, and doctors cannot prescribe treatment.
The Texas ruling has the potential to undermine the FDA's regulatory power, impacting more than just one medication. Indeed, HHS Secretary Xavier Becerra said the ruling could impact "."
Central to any pharmaceutical or device innovation is obtaining FDA approval. This control mechanism guarantees the U.S. public benefits from the safest and most advanced drug system globally. The foremost protector of consumers within this structure is the FDA's Center for Drug Evaluation and Research (CDER). This autonomous board evaluates new drugs before they come to market. This assessment process not only protects against dishonest practices but also provides doctors and patients with essential information to make well-informed choices regarding medication use. The center guarantees both branded and generic drugs function effectively and that their health advantages surpass any identified risks.
Now, that independent process could be upended.
In this ruling, the Texas judge said, "FDA acquiesced on its legitimate safety concerns -- in violation of its statutory duty -- based on plainly unsound reasoning and studies that did not support its conclusions."
That statement is false.
Mifepristone has been shown to be extremely safe -- even safer than .
If this decision is upheld, any federal judge could ban any drug -- even one that had been approved for and has been demonstrated to be objectively safe and effective.
If policymakers think price controls will have a chilling effect on innovation, imagine what will happen when drug companies know that a single judge can erase decades of research.
Controversial Drugs
The Texas judge has a long anti-abortion history. That does not mean his ruling won't set precedent for drugs other than mifepristone.
Since the pandemic began, countless FDA-approved pharmaceuticals, including life-saving vaccines and other treatments, have been politicized. We now have very vocal anti-vaccine candidates running for elected office. As previously uncontroversial medications turn into controversial subjects, what might the consequences be for their future accessibility?
Imagine this situation: a political faction maintains sexual activity should solely take place for procreation purposes. They strongly believe and reason that engaging in sexual activity outside of a reproductive, marital event is a grave sin. They also claim there is proof that a particular drug, meant to improve sexual performance, is hazardous and deadly.
While the drug may have uses for erectile dysfunction during procreative sex, the primary use is likely for non-procreative means. If an organization believes this drug is primarily used for non-procreative sexual activity, which they contend is evil, and can find "research" highlighting its dangers, could the organization file suit against the FDA hoping to ban the drug? Could the same be true with vaccinations? Or contraceptives? If the Texas judge's ruling stands, yes.
Banning the sale of mifepristone means any organization can question any drug. It also provides grounds for any company or drug competitor to bring a lawsuit against any drug. This point alone creates a significant risk for future investment and development for new therapeutics.
If that is the new landscape, why innovate?
Cost of Drug Manufacturing and Projected Revenues
The mean cost for developing a drug is . This ruling will increase those costs.
Critical to drug pricing and financial investment in research and development by pharmaceutical firms is the projected revenue from a new medication, the anticipated cost of its development, and policies that impact the availability and demand for drugs. The engine that drives drug development is the potential future profit.
This ruling creates new risk for innovators. If drugs are deemed "controversial" or have the potential for judicial review and banning, that would alter projected revenues. Companies will likely begin to avoid classes of drugs such as hormone treatment, erectile dysfunction medications, opioid use disorder treatments, psychiatric medications, or any other politically charged medication.
As investors and businesses look for places to allocate their limited resources, the potential for profits is top of mind. Money for research and development is allocated to products that have the largest market and highest potential use.
This concept isn't foreign. Consider antibiotic development.
According to the World Health Organization (WHO), "only 6 [antibiotics] fulfill at least one of WHO's criteria for innovation." The reason there are few antibiotics in development (despite growing antimicrobial resistance) is the inability to find investors. And the reason investors are hard to find is that antibiotics are simply not as profitable as cancer therapeutics or chronic disease medications. If a drug or a class of drug's profitability is threatened, investments will shift elsewhere, threatening research and development in several drug classes.
If Not the FDA, Then Who?
This ruling will undermine public trust in the autonomy of the FDA. More than from the biotech and pharma industry have said as much. And the uncertainty this ruling creates will harm drug innovators, providers, and patients. Quite simply: Replacing the opinion of a single judge for independent expert peer review will endanger public health.
is a practicing emergency medicine physician, founder of , and a professor of practice at the University of North Carolina's Kenan-Flagler Business School. Previously he served as president of emergency medicine and chief impact officer for one of the nation's largest national medical groups.