Just before the snows shut down Washington last weekend, FDA issued its annual list of intended guidance documents across the range of regulatory functions it oversees. Some of these come about through legislation; some are agency-generated when a gap in FDA policies is realized. The agency strives to meet its schedule—under transparency recommendations from former Administrator Margaret Hamburg—but the deadlines get missed, and the guidances that are issued are sometimes not quite what was expected. Guidances are not “law;” but FDA promulgates these documents with the expectation that the goals they define will be met in one or another fashion.
At any rate, the 102 intended guidances range from major industry practices to specialized therapeutic areas. Some of the highlights:
- Biosimilars: Guidance is expected on “demonstrating interchangeability with a reference product;” labeling; and statistical approaches to analyzing similarity data.
- Advertising: Guidance for “health care economic information in promotional labeling and advertising;” Internet/social media advertising and use of links to third-party sites; and communications of unapproved uses of drugs and medical devices.
- Clinical: Revised guidance for adaptive-design clinical trials; “natural history” studies for rare disease drug development; pediatric oncology.
- Generics: 180-day exclusivity; ANDA applications; 505(b)2 and 505(j) applications.
- Procedural (a catchall category for other guidances): six separate documents pertaining to the Drug Supply Chain Security Act, including annual reporting by wholesalers and third-party logistics providers, interoperability standards; and waivers and exceptions for field report submissions. Also: assessments of Risk Evaluation and Mitigation Strategies (REMS) reports; and use of electronic health records (EHRs) data in clinical investigations.
It’s going to be a busy year.