The "Food and Drug Administration Amendments Act of 2007" ("the 2007 Amendments" or "the Amendments") (P.L. 110-85) went into effect on October 1, 2007.1 These Amendments represent the most comprehensive overhaul of food and drug law since 1997.2 The 2007 Amendments implement several major changes to the Federal Food, Drug, and Cosmetic Act ("FDCA"), including: (1) the reauthorization, increase, and addition of new user fees for prescription drug and device products for another five years; (2) the increase of the Food and Drug Administration’s ("FDA") regulatory authority to monitor the safety of marketed drug products and medical devices; (3) the addition of incentives for development and oversight of pediatric drugs and devices; and (4) the strengthening of food safety requirements. These Amendments do not include provisions to permit FDA approval of generic or "follow-on" biologics, a contentious topic that continues to be debated by Congress.

More specifically, the 2007 Amendments give FDA the authority to:

  • Require post-approval labeling changes to strengthen safety information on prescription drugs,
  • Impose new civil money penalties for certain violations of the FDCA,
  • Collect fees for advisory review of television advertisements for prescription drugs,
  • Assess special user fee rules for positron emission tomography drugs, and
  • Apply new annual fees for registration of device establishment and filing periodic reports.

The 2007 Amendments also provide medical device manufacturers with additional incentives to develop certain medical products. In particular, the Amendments:

  • Provide incentives for the development of medical devices for pediatric patients,
  • Permit humanitarian device manufacturers to make a profit, and
  • Include provisions to streamline third party device inspections.

FDA will also benefit from expanded food safety authority. The agency is now required to take proactive steps to ensure food safety, including the establishment of the following:

  • An early warning and surveillance system to identify pet food adulteration and associated illnesses,
  • Processing and ingredient standards for pet food,
  • Improved communication requirements for ongoing recalls of both human and pet food,
  • Procedures to work with the states to improve the safety of fresh and processed produce, and
  • An Adulterated Food Registry with alert procedures.

FDA has also received additional oversight responsibilities for genetic test safety and quality, and the 2007 Amendments provide exclusivity for certain drugs containing enantiomers.

The following includes a table of contents and a detailed summary of the FDA Amendments Act of 2007.

To view the Table of Contents and continue reading this article please click here.

Footnotes

1. President Bush signed the Food and Drug Administration Amendments Act of 2007 (P.L. 110- 85) into law on September 27, 2007. The law was enacted on October 1, 2007.

2. In 1997, Congress implemented sweeping changes to FDA’s responsibilities and authority under the Food and Drug Administration Modernization Act of 1997 ("FDAMA")

This article is presented for informational purposes only and is not intended to constitute legal advice.