James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Axios, in “Drug Industry Worries About FDA Delays,” by Tina Reed.
Following is an excerpt:
Pharmaceutical companies are growing increasingly concerned widespread cuts at the Food and Drug Administration could set the agency back as crucial review deadlines loom.
Why it matters: Health industries pay billions developing and shepherding drugs through the regulatory process, including user fees that help ensure there are enough staff to evaluate products on a predictable timeline.
There are dozens of expected approval dates scheduled for drugs and biologics in the next three months. They include a monoclonal antibody for RSV from Merck, as well as expanded uses for a GlaxoSmithKline drug for COPD and a Gilead drug for HIV prevention.
As yet, there have been no delays to drug approvals, but industry watchers worry that may not last in light of the agency job cuts. On Wednesday, CBS News reported the FDA is planning fewer food and drug inspections as a result of reductions in the FDA's Office of Inspections and Investigations.
Potential delays would not only be costly to drug makers, particularly smaller manufacturers, but can drive up prices for patients waiting for innovative treatments, experts say.
HHS did not immediately respond to a request for comment.
The big picture: By the time companies file new drug applications, they typically are far enough along in the review process that there is an expected timetable for how long it will take to get their products evaluated.
When those dates are delayed, it can make the investment community jittery and can be destabilizing from a business perspective, said Epstein Becker Green partner James Boiani. "If you're talking about a brand innovator product, you're losing patent life each day. If it's not approved, the asset's really depreciating," Boiani said.
And, he said: "If you have a drug that's safe and effective, but it's kind of sitting on the shelf because someone doesn't have time to review it, that's a public health detriment as well."
