Drug Compounding Authority. In response to the NECC fungal meningitis outbreak, Representative Edward Markey (D-MA) introduced new legislation to expand FDA authority over prescription drug compounders. The issue frequently pits drug manufacturers and consumer advocates against pharmacies and state pharmacy boards/attorney generals. The Senate Health, Education, Labor & Pensions Committee will hold an upcoming hearing on the NECC matter and the underlying division of responsibilities between FDA and state pharmacy boards. The role played by tough FDA enforcement of CGMP interpretations to close down generic injectable drug manufacturers may be examined as a model for enforcement in this area. FDA also might request an expansion of its establishment inspection authority under Section 704 of the Food, Drug and Cosmetic Act in order to determine if compounding pharmacies are operating as drug manufacturers. Committee Chairman Tom Harkin (D-IA) and Ranking Member Michael Enzi (R-WY) are preparing to introduce a bipartisan compounding bill after gathering more information at this hearing. Compounding legislation could serve as a vehicle for other FDA-related reform efforts for which consensus was not reached in the “must-pass” FDASIA legislation (e.g., electronic drug pedigrees).
Genetically Modified Organism (GMO) Food Labeling. California’s failure to approve Proposition 37, the GMO labeling law, may slow the momentum of federal GMO labeling initiatives. The defeat of Proposition 37 diminishes the prospects for a similar federal GMO law in the near future. Criticism of Proposition 37 focused on its potential for excessive litigation through citizen suits and the wide scope of liability that encompassed food retailers. In addition, opponents of Proposition 37 had significant financial backing from agribusiness and chemical companies as well as food manufacturers. Any federal initiative would probably need a different legal format than Proposition 37 and would also have to contend with significant opposition from industry.
Caffeine Labeling for Energy Drinks. Caffeine labeling is on FDA’s radar with the recent deaths associated with high caffeine energy drinks, which are marketed as dietary supplements. Adverse health events from these drinks often occur in youth, making this an issue of particular public concern. In addition, Senators Richard Blumenthal (D-CT) and Richard J. Durbin (D-IL) wrote a letter to FDA urging investigation into the health risks of high caffeine energy drinks. The agency is currently investigating the matter and there is a potential for new rules or guidance with respect to caffeine labeling in dietary supplements.
Track and Trace Requirements. Although Congress tackled a variety of drug issues as part of FDA user fee legislation in July 2012, the final version of FDASIA did not include pharmaceutical supply chain integrity requirements. During consideration of the user fee legislation, policymakers could not reach agreement on “track and trace” language, including whether the pharmaceutical supply should be tracked at the unit or lot level. With the user fee legislation moving forward without “track and trace” requirements – and with state level requirements in California set to take effect in the coming years – Congress is expected to return to this issue in the near future.
On October 24, 2012, a bipartisan, bicameral working group unveiled a “Draft Proposal to Improve Drug Distribution Security.” This discussion draft reflects the ongoing effort to develop consensus policy on drug distribution security, including track and trace requirements. The draft legislation would initially establish a lot level tracing system with a pedigree requirement. Under this system, manufacturers would be required to affix a product identifier to each saleable unit. The legislation also sets the groundwork for a unit level tracing system that would be put in place in later years through rulemaking, following a series of pilot programs and public meetings. Congressional staff is currently reviewing input from members of Congress and stakeholders on the draft and are working to develop consensus.