Experts in industry, academia and on Capitol Hill agree that FDA has been chronically underfunded and understaffed. The result is that FDA's ability to ensure the safety and efficacy of food, drugs and medical devices is severely compromised. Agency leadership has been forced year after year to make difficult decisions about where to infuse funds and where money should be cut. These tough decisions have frequently been made at the expense of other critical regulatory duties, putting the safety of our food, drug and medical devices at great risk. FDA reform is a top priority of President-elect Obama and a bipartisan majority in Congress. A change in leadership at the Agency, including the Commissioner, Chief Counsel and others, will likely bring increased focus on product safety.

We can expect FDA reform to impact every segment of the health and life sciences sector. Despite the significant broad reforms that will certainly create some new challenges and hurdles for our clients to navigate, discussion around FDA reform affords a unique opportunity for every segment of the health and life sciences sector to participate in crafting positive changes that will result in a stronger agency and a safer food, drug and medical device supply chain.

Devices

The safety and efficacy of medical devices is an area of bipartisan interest and will be a key component to a comprehensive FDA overhaul. We expect several issues to be at the forefront of this discussion:

  • Pre-emption: In response to Riegel v. Medtronic, in which the Supreme Court ruled that patients injured by defective medical devices cannot sue for damages in state courts if FDA approved the product, key Congressional leaders are pursuing legislation to state explicitly that FDA regulation does not trump the ability of consumers to seek damages under state law. We expect that the issue of pre-emption — for both devices and pharmaceuticals — will be revisited and addressed in any FDA reform legislation in 2009.
  • Unique Device Identifier (UDI): Congress is increasingly interested in ensuring post-market safety of drugs and medical devices, and discussion about appropriate ways to achieve greater safety and efficacy of devices has included whether or not to utilize UDI. Industry is resistant to this proposal and has asserted that such a system should be voluntary, except where there is a patient safety issue best addressed through use of a UDI. Given the expanded Democratic majorities in Congress and an increasing emphasis on post-market safety, the debate over UDI and other post-market surveillance tactics is expected to continue.
  • Third-party inspections: Congress implemented third-party inspection programs in response to unstable funding of FDA through appropriations and user fees, and as a way to bolster FDA's inspection responsibilities. Congress is expected to increase the FDA budget through appropriations but will be challenged to do so facing budget constraints. We can expect to see reforms to the third-party program to protect further against conflicts-of-interest and increase the number and quality of inspections, but we do not foresee an end to this tactic in the near term.

Food and Drugs

Because of increasing concerns about the repeated shortfalls of FDA in ensuring food and drug safety, we can expect comprehensive FDA reform to include policies bolstering FDA’s ability to oversee food and drug imports and safety. This has already been signaled by the recent update to the Center for Drug Evaluation's (CDER's) Manual of Policies and Procedures (MaPP) directing greater coordination of safety oversight between the Office of New Drugs (OND) and Office of Safety and Epidemiology (OSE).

We anticipate new food and drug legislation will likely focus around the following policy issues:

  • Assessing user fees to support new FDA authorities
  • New FDA mandatory recall authority for tainted food and drugs
  • New FDA registry of all food, drug and device facilities serving U.S. consumers
  • Implementing a traceback system (particularly for meat, poultry and egg products from farm to store)
  • Establishing Country-of-Origin-Labeling (COOL) requirements for processed food and drug imports
  • Allowing expedited processing for trusted importers.

Biologics

Many of the original patents on biotech products (biologics) are expiring, and there is growing interest across the health and life sciences sector for the creation of an expedited pathway for the approval of “follow-on biologics” (also referred to as generic biologics; biogenerics; biosimilars), generic versions of biologics intended to compete with the original product. Congress faced a similar dilemma with pharmaceutical products in the 1980's and responded with enactment of the Drug Price Competition and Patent Term Restoration Act of 1984 (also referred to as Hatch-Waxman after its lead authors: Representative Henry Waxman, D-California, and Senator Orrin Hatch, R-Utah), which was designed to promote generic drugs while providing a financial incentive for research and development. Biosimilars have already been the subject of vigorous debate in Congress and will continue to be discussed in 2009.

What should you do to prepare?

  • Consider proactive strategies for increased post-market surveillance activities. Comprehensive FDA reform is expected to include expansions of post-market surveillance of drugs, biologics and devices. Medical technology manufacturers should pay careful attention and prepare for FDA to rely heavily on Risk Evaluation Mitigation Strategies (REMS) and other post-market safety strategies. As the new ClinicalTrials.gov registration database evolves to include a results database, consumers and industry should also prepare to play an active role in the collection and monitoring of post-market safety data.
  • Develop effective and appropriate strategies for educating patients and physician customers about new drugs and therapies. We are likely to see interest in making mandatory the direct-to-consumer (DTC) advertising review program established under the Food and Drug Amendments Act (FDAAA) for prescription drugs and perhaps expanding the program to include other products like dietary supplements, medical devices and biologics. As a result, medical technology marketing strategies to patient and physician customers will be more closely scrutinized. Patient groups and industry should develop strategies for educating patients and physicians about new drugs and therapies that are consistent with emerging regulatory and ethical requirements.
  • Prepare a strategy to advocate for responsible biosimilar legislation and respond to regulatory action. Biosimilars legislation will significantly impact every player in the health and life sciences, including:
    • Patients: Research and development of new therapies may be stifled if incentives are lacking. Patient safety may be a concern if biosimilars do not exactly replicate the original product. Patients may have more product choices. Out-of-pocket savings are a reality.
    • Biotechnology companies and third-party patent holders: Incentives for research and development of new biologics (such as offering additional market exclusivity in order for companies to make up for the time a biologic was in development), and respectful treatment of innovators' patents and trade secrets must be present in order to drive future innovation.
    • Providers and health care systems: Providers will need to be educated about new therapies and whether they affect patients in the same way as an original product. Providers may also have more treatment options. Biosimilars are expected to generate significant savings to federal and private health care systems.
  • Advocate for increased appropriations to FDA and develop alternatives to user fees to support review and post-market safety activities. There is precedent for relying on user fees to support FDA’s budget for drug, biologic, device and animal drug review activities when appropriations are unavailable. Under FDAAA, Congress expanded the user fee program to include support of some post-market safety activities as well as review of DTC ads. We are likely to see an increase in appropriations to FDA, which could relieve some of the burden for industry. However, given the practicalities of today's spending environment, we do not foresee a scaling back or complete end to the user fee program.