James Boiani Quoted in “What’s Next for the Post-Gottlieb FDA”

MM&M

James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MM&M, in “What’s Next for the Post-Gottlieb FDA,” by Alison Kanski.

Following is an excerpt:

Although Gottlieb has moved on, health policy experts believe the FDA will stick to the course he set during his two-year tenure — and most regard less uncertainty as good for the pharma business. …

Gottlieb’s Enduring Legacy

Hallmarks of the FDA the past two years have included streamlining the drug-approval process and addressing drug prices through increased generic and biosimilar competition. Outside of pharma, Gottlieb made e-cigarettes a major focus, cracking down on teen use and threatening more than once to pull the product from the market completely.

Gottlieb also pulled the FDA into the drug-price debate, an arena the agency had not been part of before.

“It’ll be good for pharma, and ultimately for patients and payers, too, particularly on drug-pricing issues and ways to make drug approval more efficient,” says James Boiani, an attorney in the healthcare and life sciences practice at Epstein Becker Green. “There’s an understanding of the FDA’s role in the process and how it can impact pricing. Drugs coming to market more quickly will continue to be a focus at FDA because of the administration’s focus on drug pricing.” …

While some note that tobacco companies are capitalizing on the transition between Gottlieb and Sharpless to lobby against the regulations placed on e-cigarettes, experts say the pharma industry is not planning to do the same.

The FDA’s changes to drug approval have largely been good for pharma, especially companies that make generics and biosimilars. Even the branded drug manufacturers that have pushed for faster review times are seeing the benefits of Gottlieb’s FDA.

Boiani says pharma’s laundry list for the next FDA chief could include continuing to speed up the drug development and approval process, along with more movement on approving combination products of drugs and devices.