Now that the election of 2012 is history, the there is speculation among FDA watchers as to what the re-election of the President means for the FDA. Bottom line: present leadership will remain so expect no major policy changes.
People: Commissioner Margaret Hamburg could become the longest serving Commissioner in modern history. While some changes in her staff are inevitable, her staff will largely remain in place.
More important from a product-specific standpoint, the leadership at the drug, biologics and device centers—CDER, CBER and CDRH—will remain. Of particular importance is the continued leadership of Janet Woodcock at CDER, which will help assure the implementation of the data collection and monitoring programs underway, as well as expansion of the rare disease/orphan drug program.
Drug approvals: The drug approval process would be significantly affected if Congress fails to resolve the budget crisis. The entire industry is vested in a rapid resolution of the budget situation. Major provisions in the FDA Safety and Innovation Act could make the approval process more transparent and predictable. If the budget issues are resolved, look for FDASIA-inspired procedural innovations.
Advertising/promotion regulation: The FDA leadership has left policy and enforcement to CDER and CBER. They have identified a series of guidances, including social media guidances, that they are working on, and they will trickle out in the next few years. Look for no change in policies or enforcement.
Bottom line on election: Policy stability at FDA, look for drug approval process changes because of FDASIA, hope Congress resolves the budget issues.
Wayne Pines is President of Healthcare and Regulatory Services at APCO Worldwide