What impact could a Texas lawsuit have in California, on the availability of a drug prescribed for medication abortion? KVCR’s Jessica Greenwell spoke to Ramona Thomas, legal counsel for Planned Parenthood of Orange and San Bernardino Counties, to find out.
Jessica Greenwell: So, although abortion is legal and now constitutionally protected in California, what is the potential impact to California residents if the Texas law results in a ban of Mifepristone?
Ramona Thomas: In Texas, the current case is set in the federal court, and essentially challenges the FDA’s approval of Mifepristone as a drug that can be used nationwide for medication abortion. So essentially, even though we have constitutional protections in place that cover access to the procedure itself, the unavailability of the medication would really impact women’s ability to receive that particular medication, and to receive the easiest and most effective medication abortion currently on the market today.
Jessica Greenwell: What is the connection between this challenge to the FDA and the claim that mifepristone was fast tracked and the Comstock Act?
Ramona Thomas: The anti-abortion group that is bringing this lawsuit is challenging the FDA’s approval of mifepristone on three grounds:
First, it’s alleging that the FDA used the wrong authority and did not properly approve this drug in the first place.
Second, they’re challenging the later limitations on the drug’s access that got passed through the years to clarify how access to the drug could be accommodated.
Third, they’re alleging that the FDA could not possibly have complied with the federal Comstock laws which are laws from the 1800s that illegalized what they considered to be obscene materials sent through the U.S. mail. The position of the government and of the actual manufacturer of mifepristone is that none of these challenges are legally sound and in fact, the plaintiffs do not have standing and these cases are procedurally barred.
Jessica Greenwell: What could a decision like this mean in the future with challenges to the FDA’s authority? What other possible ramifications could you foresee with medication bans?
Ramona Thomas: It really is an unprecedented attack on the FDA’s autonomy and independence. Essentially, this could undermine the entire structure by which the FDA evaluates and approves drugs because it opens up any drug to political challenge in a court regardless of the safety or efficacy that was determined by the FDA during the original approval process. That’s just never happened before and it significantly impacts not just drugs that are on the market now, but drugs that researchers may be interested in trying to pursue in the future.
Jessica Greenwell: And while a decision has not yet been reached, Judge Kacsmaryk held a hearing a couple of weeks ago and indicated that he would issue an order as soon as possible.