A regulatory roll back no one seems to like … except the regulators 

Tucked into the Senate HELP Committee’s sweeping health care costs package is a section that, at least on its surface, aims to make it easier for new biologic drugs to come to market. But it turns out the drug industry isn’t so jazzed about the idea. 

Section 207 of the package strikes regulations that require biologic makers to follow quality standards developed by the U.S. Pharmacopeia. And surprisingly, industry doesn’t see why those rules need to go. In fact, they think the provision could have some serious negative consequences, including making it harder for companies to develop products, and diminishing trust in these cutting-edge products. 

“There is no compelling or credible reason to change the law to remove USP from the framework that has protected Americans for 80 years,” the Association for Accessible Medicines, the biosimilars trade group, wrote in May. (BIO, the lobby group for the branded biologic industry, declined to comment for this newsletter.) 

And they’re not the only ones: Liberal-leaning advocates including Families USA, Medicare Rights Center, and a slew of labor unions wrote a new letter last week urging Senate leadership to strip the provision before the bill hits the Senate floor.

So why is it being pursued? All signs point to the FDA, which has called the requirement “the kind of redundancy and unnecessary burden within a regulatory approval pathway that the FDA seeks to avoid.” The agency didn’t respond for this newsletter, but in a recent blog post, it argued the FDA has its own biologic quality standards and that these additional requirements could slow approval of these critical drugs.