Challenges ahead

Although the negotiated goals will go a long way in improving the safety of drugs in the supply chain, there were some disappointing aspects of the final plan. Industry associations hoped for faster implementation timelines than were identified in the FDA Performance Goals letter. For example, it is expected that inspection parity will increase confidence that drugs produced in foreign facilities are safe, but that goal is not expected to be met until 2017.

BPTF and EFCG also hoped for issuance of GMP certificates similar to those issued by European Union inspectorates. However, rather than issue these certificates, FDA will use an online database to indicate the inspection status of a facility. This database went online before approval or implementation of the GDUFA program and displays a site's status, if inspected in the calendar years 2009 and 2010. However, it is the BPTF's opinion that although the database is useful, providing that it is updated by the FDA in a timely manner (which is not currently the case), it will not be as useful to industry as a GMP certificate. In addition, it is unknown whether other regulatory agencies or drug-ingredient customers will accept this database status as an alternate to a formal GMP certificate.

The aims of GDUFA are important to American consumers, who can expect a safer and more efficient drug supply, and to the industry, which can expect a more level playing field. However, until the program is written into law, little progress will be made. While FDA indicates it will implement some review and inspection efficiencies immediately, many of the negotiated goals of GDUFA are several years away. BPTF and other organizations intend to work with Congressional representatives and their staff members to emphasize the importance of this initiative and encourage rapid evaluation and implementation.

This work should build on previous interactions with Congress, including the Sept. 14, 2011, testimony before the US Senate Committee on Health, Education, Labor and Pensions (HELP) carried out by Deborah Autor, deputy commissioner for Global Regulatory Operations and Policy at FDA, and other leading industry representatives.

GDUFA is limited to generic drugs. Similar oversight of manufacturing sites making branded drugs and over-the-counter drugs is also needed, especially for those sites making APIs. It is hoped that the increased inspectional resources focused on foreign manufacturers under GDUFA will increase the inspection frequency and oversight of all foreign facilities. BPTF and EFCG encourage FDA to further collaborate with other countries with mature regulatory systems to recognize each other's inspections. Manufacturing sites often receive multiple inspections from different regulatory agencies focused on the same products and facilities. These duplicative efforts may be better spent inspecting sites with less mature regulatory agency oversight that may not have ever experienced a thorough regulatory audit.

In the near term, BPTF is pleased with the recent GDUFA initiatives and fully supports its promotion into law by Congress. Patient safety will be increased through increased application reviews, more frequent inspection of foreign facilities, and speedier access to safe and effective generic medicines.