Consulting Firms Are Busy in Wake of Stronger FDA Enforcement, Lachman’s Sturgeon Reports

Heightened scrutiny of drug manufacturers by FDA has led to an increase in warning letters, injunctions and import alerts, and in turn has significantly increased the demand for consulting services, Lachman Consultants’ President Roy Sturgeon told the participants in an investor “conference call” sponsored by New York-based Lazard Capital Markets (LCM) on June 22.

“We are in an unprecedented era in drug enforcement,” Sturgeon explained.  “We have 300-400 active clients – everything from one-person entrepreneurial firms all the way up to the largest pharma companies.  Nobody is being spared the scrutiny of FDA.”

LCM billed the conference call as designed to inform its clients about how FDA enforcement actions against drug manufacturers could “become a major point of consternation for investors” in the immediate future.  The financial company’s focus on FDA enforcement speaks to the agency’s success in raising the importance of manufacturing compliance to the executive community.

Sturgeon highlighted the impact that increased enforcement has had on his firm.  “I would say our volume of inquiries and work has more than doubled in the last year,” he noted, adding that Lachman consultants are spending considerable time with firms who have received 483s as well as warning letters.

Subscribers can read more about the Lachman president’s assessment of the changing inspection landscape here.