The Texas abortion pill ruling threatens pharma innovation

Drug makers will worry about heightened regulatory uncertainty

- LISA JARVIS

A Texas federal judge’s ruling to take the 23-year old drug mifepristone off the market not only threatens abortion access in the US, it’s an appalling sideswipe at the Food and Drug Administration’s (FDA) authority and expertise. If allowed to stand, it will have a stifling effect on pharmaceutical innovation. Developing a drug is expensive: the average cost of bringing a new medicine or vaccine from idea to market is anywhere from a few hundred million dollars to more than $2 billion.

Companies make that investment on the assumption that their products can be sold anywhere in the US for a certain number of years—that they will come out on the other side of the FDA’s rigorous review process with a product that doctors consider safe and effective enough to prescribe, patients trust enough to take, and insurance companies regard as worth paying for. They know that if an issue arises with their product, the FDA has a well-defined (albeit imperfect) process for stopping its sale. The agency’s stamp has become the gold standard for regulatory authorities around the world.