Yahoo Finance Drug CEO: How the industry is fighting to sway impact of Texas abortion pill ruling
The battle brewing over the Texas abortion pill ruling was not something the drug industry originally expected to get traction. But when it did, Ovid Therapeutics CEO Jeremy Levin said, big pharma had to move quickly.
"We actually thought it would never go anywhere, originally," Levin told Yahoo Finance Wednesday (see video above) prior to an appeals court ruling.
"As it got momentum in the court, we felt we had to take action," he added.
That came in the form of a letter to condemn the Texas ruling last week that now has more than 500 signatories, including notable names the likes of Pfizer (PFE) and Biogen (BIIB).
The U.S. Court of Appeals for the Fifth Circuit offered some temporary relief but with significant restrictions for the use of the abortion pill mifepristone late Wednesday. The court allowed the use of the pill to continue but put in some limitations and would remove the mail order option that the FDA began to allow in January.
The appeals court is reviewing arguments from the Texas ruling last week. Meanwhile, the Department of Justice is asking the U.S. Supreme Court to block the appeals court decision and leave widespread mifepristone access untouched.
But how the case plays out is something the entire $860 billion drug industry is watching closely. In addition to the letter, some companies have joined an amicus brief, filed by the pharma lobbying group BIO, to challenge the Texas ruling.
"If we do not stop this, what will happen is you've opened the door to a complete abrogation of the mandate that Congress has given to the FDA. The FDA is the only body with medical and scientific capabilities for assessing new medicines," Levin said.
If a judge can interfere, Levin added, it would upend the entire drug development process in the U.S.
A litigious business
Even though drug development is generally a high-risk and litigious business, the ruling to ban an FDA-approved drug would set a new precedent, experts say.
Drug companies often engage in patent battles or defend against injuries caused by drugs, as seen in the high-profile cases of the opioid lawsuits and the Johnson & Johnson talc case. Those are acceptable uses of the court, Levin said, but this case is different.
"If now a politically motivated group can sue with an individual judge and overturn decades of scientific and medical evidence without having any of that experience, you throw into question the entire ability to approve a drug appropriately," he said.
Industry advocates have said it could impact innovation — an argument that was previously used in the debate around drug pricing.
Kayte Spector-Bagdady, a bioethicist and interim co-director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan, told Yahoo Finance that is a valid argument.
"The FDA and the pharmaceutical industry have a symbiotic relationship," Spector-Bagdady said. "On average it costs over $1M to conduct the science, clinical testing, and FDA interface required to bring a new drug to market. Since the 1930s, the pharmaceutical industry has relied on authorization from FDA to sell safe pharmaceuticals via a predictable regulatory process."
Spector-Bagdady is a former FDA attorney for several pharmaceutical and biotech companies and served as the associate director for former President Barack Obama's Bioethics Commission.
She said that the letter circulated by the companies was both courageous and self-serving.
"If individual judges with erroneous medical information are allowed to overrule the thorough and expert review of FDA, then that scares pharmaceutical companies from investing the hundreds of millions of dollars necessary to develop new drugs. So, it was certainly in their own self-interest to respond to Judge Kacsmaryk’s case," she said.
"The central point of the letter is that all drugmakers need to be able to rely on the FDA approval process to calculate the risks of investing an enormous amount of money to bring drugs to market," Spector-Bagdady said.
Follow Anjalee on Twitter @AnjKhem
Click here for politics news related to business and money
Read the latest financial and business news from Yahoo Finance
