The Food and Drug Administration plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices. There will be more advice on establishing a quality system approach to current good manufacturing practice (GMPs) and on quality agreements with contract manufacturers, according to the 2014 guidance agenda for the Center for Drug Evaluation and Research. Other documents will address use of cloud computing systems in manufacturing, interim GMPs for drug compounding outsourcing facilities, submission of field alert reports and biological product deviation reports, and electronic filing of information on manufacturing establishments.
Specifically related to chemistry, manufacturing and controls (CMC), FDA plans to provide advice on analytic procedures and methods validation, appropriate packaging for injectables drugs, CMC information in comparability protocols, evaluation of near infrared spectroscopy methods, CMC and other documentation for liposome drug products, and labeling vial fill size.
Further information is expected on developing biosimilars, including the hot topic of demonstrating interchangeability to a reference product. There also will be advice on developing pharmacology data, on labeling biosimilars, and on reference product exclusivity. Other guidances will clarify approaches for developing new analgesics, drugs for rare diseases, and treatments for chronic fatigue syndrome and infectious diseases. FDA also plans to clarify best practices in developing drug proprietary names and on distributing drug samples. And there will be advice on identifying suspect products and tracking drugs, as required by the Drug Quality and Security Act.
More guidance on Internet/social media communications is expected this year – one on presenting risk and benefit information in limited space, another on correcting independent/third party misinformation about a drug or medical device, and a third on appropriate use of website links. And a long-anticipated document on using the “brief summary” to disclose drug risk information may finally emerge.
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 costs, according to the 2014 OIG work plan. The investigators plan to examine how often and how well FDA inspects generic drug manufacturing facilities and what enforcement actions result – a new probe evidently generated by concerns over drug shortages and regulatory lapses by major generic drug makers such as Ranbaxy.
The OIG also will analyze whether Medicare pays too much for drugs, as seen in plans to examine the effect of reporting based on average sales price vs. average manufacturer prices; if Medicare Part B should have access to 340B pricing; if payments are appropriate for off-label drug uses, namely for immunosuppressive drugs and for chemotherapies; and if prescription drug compendia are developed fairly and transparently.
Medicare Part D drug benefits face considerable 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 co-pay coupons, as required by the rules.