As new faces and agendas emerge in Washington, pharmaceutical companies will face multiple challenges in developing safe and effective therapies that are affordable to patients and payers alike.
At the same time, a de-regulatory approach that challenges FDA restrictions on industry communications and promotional activities could lead to important policy changes for marketers. In response to legal challenges on several fronts, FDA held a public hearing in November to discuss proposals for revising policies that limit the dissemination of off-label information. Biopharma companies cited the benefits of discussing additional uses of medicines with health professionals, while FDA officials and consumer advocates raised concerns about permitting wider promotion of unproven claims (for the patient advocate viewpoint, read “Patients with Chronic Conditions Are OK With Off-Label Drug Promotion: If FDA Allows It, Will Pharma Do It?”: http://bit.ly/pmn150501p).
Marketers also hope FDA will revisit its regulatory approach to social media communications (read, for example, “FDA to Study Space-Limited Communications. Will It Help Pharma Market Drugs on Twitter & Facebook?”: http://sco.lt/5DbIqf) and current curbs on how companies may respond to queries about unapproved uses at public meetings and through online postings. An early win could come from clarification of FDA policies for disseminating economic information on products to health plans and formulary committees. A more flexible approach was originally proposed in section 114 of the 1997 FDAMA user fee legislation, but never implemented; language in the the 21st Century Cures legislation supports such action.
Added pressure to scale back oversight of drug safety and efficacy raise the risk that key FDA officials will depart and leave these challenges to others, as seen in the recent retirement of John Jenkins, long-time head of FDA’s drug approval office and widely praised as fair-minded and dedicated to public service (read “Sarepta Critic Jenkins Thrown Under Bus as Janet Woodcock Takes Charge of FDA's Office of New Drugs”: http://sco.lt/8CkEpl). His skill in explaining the complex issues related to difficult regulatory decisions will be sorely missed.