The FDA leans forward: Dr. Scott Gottlieb’s opportunity to reshape the agency

Overview

The FDA’s new commissioner, Dr. Scott Gottlieb, has extensively argued that the agency is in need of regulatory reform meant to get critical medical products to patients more quickly and efficiently. Gottlieb’s previous statements signal a greater likelihood of significant change at the FDA, which has been given new authority – both statutory and executive – by legislators and President Donald Trump to streamline and accelerate the way it regulates. Gottlieb has indicated he is aligned to this vision. As change takes place, life science companies may benefit and find reasons to celebrate – but so, too, will their competitors.

 

Key findings

Faster approvals, faster competition

Though expedited regulatory approaches may substantially benefit some companies—in particular pharmaceuticals marketers—that efficiency also will extend to their competitors. Existing patent protection and decades of legal precedence will still limit what the FDA can accomplish in some cases, but such competition can reduce prices—and profits—for some product categories. Companies should ensure they fully understand the FDA’s new authorities under the 21st Century Cures Act, and closely monitor the FDA as it creates, modifies and removes regulations and guidance under Gottlieb. Companies also should prepare for the new FDA Reauthorization Act, which—once enacted—would position Gottlieb to oversee the implementation of another major piece of regulatory legislation intended to modernize the agency.

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Prepare for change

Expedited approvals for some products will mark new competition for some manufacturers. Some change could reduce public trust in some products or the regulatory approval process. A slowdown in releasing regulation or guidance could be a hurdle for life science companies looking for certainty before investing billions in new drug development. Some older regulations’ elimination could introduce uncertainty into existing product categories. As changes hit the FDA and Washington, the life sciences industry should be prepared to weigh in on those changes early and often and make sure it deeply understands the complex ways in which even minor changes can cascade across the industry.

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Risks in any approach invite eventual pushback

The history of nearly all drug and device regulation can be traced to specific safety scandals or major concerns. The life science industry will need to closely track the use of specific regulatory authorities, as overuse or improper use of some approval pathways could lead to regulatory or Congressional pushback, or public scrutiny.

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Contact us

Benjamin Isgur
Health Research Institute leader
Tel: +1 (214) 754 5091
Email

Trine K. Tsouderos
HRI Regulatory Center Leader
Tel: +1 (312) 241 3824
Email

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