FDA Guidances, OIG Investigations to Shape Drug Marketing, Research

Marketers may see further advice from the Food and Drug Administration in the coming year that clarifies how they can use social media. Priority topics:  presenting risk and benefit information in limited space; correcting independent/third party misinformation about a drug or medical device; and appropriate use of links, according to the agenda for the Center for Drug Evaluation and Research on issuing new and revised draft guidance documents in 2014. Also in the “advertising” category is a long-discussed document on using the “brief summary” to disclose drug risk information. And FDA will advise on electronic submission of promotional labeling and advertising materials.

FDA also expects to issue more guidance on developing biosimilars, including a highly anticipated document on demonstrating interchangeability to a reference product. Other advisories will address biosimilar labeling and reference product exclusivity. FDA also plans to clarify best practices in developing drug proprietary names and distributing drug samples. There are plans for documents to clarify approaches for developing new analgesics, drugs for rare diseases, and treatments for chronic fatigue syndrome and infectious diseases. And there will be advice on identifying suspect products and on tracking drugs as required by the Drug Quality and Security Act.

At the same time, the Office of the Inspector General (OIG) of the Department of Health and Human Services will be busy investigating a number of issues related to drug regulation and reimbursement, as listed in the 2014 OIG work plan. The investigators will examine how often and how well FDA inspects generic drug manufacturing facilities and what enforcement actions result – a new investigation evidently driven by concerns over drug shortages and regulatory lapses by major generic drug makers such as Ranbaxy.

The OIG also will assess whether Medicare pays too much for drugs, as seen in plans to probe the effect of basing reporting on average sales price vs. average manufacturer prices; whether Medicare Part B should have access to 340B pricing; if payments are appropriate for off-label drug uses, as well as for immunosuppressive drugs and for chemotherapies; and if prescription drug compendia are developed fairly and transparently.

Medicare Part D drug benefits are under scrutiny, as seen in a long list of investigations into plan billing and payment practices. The OIG also will examine whether retail pharmacies provide appropriate discounts on generic drugs; if rebates on brand-name drugs reduce plan spending sufficiently; and if Part D plans prevent the use of manufacturer copay coupons, as required.