FDA and industry square off over approval process

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In 2012, the FDA will seek congressional reauthorization of two acts related to drugs and medical devices. The battle lines have been drawn as industry has slammed the burdensome FDA approval process and its consequent defection of innovation from the U.S. to Europe, while the FDA testified before Congress about its robust approval process and innovative plans to make it even better.

In February, the California Healthcare Institute (CHI) issued a report, "Competitiveness and Regulation: The FDA and the Future of America's Biomedical Industry," to coincide with the U.S. House Energy and Commerce Committee Health Subcommittee's hearing on the impact of medical device regulation.

"The data clearly indicate that today's FDA is not keeping pace with U.S. biomedical innovation," wrote David Gollaher, PhD, president and CEO of CHI, in the report. "The agency-industry partnership is strained by unexplained regulatory delays, by a lack of clear standards for what clinical data are necessary for product approval and by a bureaucracy whose communications are neither consistent nor predictable."

Testifying before Congress on Feb. 17, Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health (CDRH), acknowledged that "in many areas, insufficient clarity, consistency and predictability on our part contributes" to the expense of medical device development. Yet, Shuren had many positive things to say about the agency's performance over the last decade.

The CHI report mentioned some points of discontent, including:

  • Comparing the most recent year for which a representative set of submission data is available (2008) with the average for 2003 to 2007, review times for drugs and biologics have increased by 28 percent.
  • For medical devices, comparing 2010 with the period 2003 to 2007, 510(k) clearances have slowed by 43 percent and premarket approval (PMA) times have lengthened by 75 percent.
  • Where new medicines were approved first in the U.S. by an average of nearly seven months between 2004 and 2006, recent data show products approved on average two-and-a-half months earlier in the European Union (EU), a shift of nine months.
  • Complex medical devices approved via the PMA process in the U.S. are approved in Europe on average nearly four years ahead of the U.S., up from just over a year earlier this decade.

Class III devices, which are the highest risk category of devices, are subject to PMA application containing scientific evidence of the devices' safety and effectiveness.

Shuren took notable exception to the comparison with the EU model of approval. First, the CE mark conferred on products in the EU does not prove the device's effectiveness, only its safety and performance, meaning the device must perform as indicated in the device description and is not required to show benefit to the patient.

"For example," Shuren testified, "if a manufacturer wishes to market a laser to incise heart tissue to treat arrhythmia in the EU, the manufacturer must only show that the laser incises heart tissue. In the U.S., however, the manufacturer must show that the laser incises heart tissue and also treats the arrhythmia."

He also pointed out that, unlike the U.S. medical device regulatory system, the European system:

  • Does not require government review before a company may market a device;
  • Allows manufacturers to "forum-shop" their applications among third-party reviewers who are subject to minimal oversight;
  • Provides minimal information to the public about the evidence supporting company claims;
  • Has no centralized authority for tracking safety information related to medical devices and no EU-wide post-market surveillance system; and
  • Has no centralized database of information about the performance of the various regulatory systems, making it difficult to compare the performance of the EU and U.S. systems.

The CHI report touted the EU approval process as one that is transparent and fosters innovation, "a consistent path that enables the EU's regulatory agencies to deliver on their 210-day time limit for new drug application reviews and the 90-day limit for Class III medical devices."

The report also noted a correlation between a device's complexity and its longer lag-time to approval in the U.S. In fact, "the more complex, and often cutting edge, a product is, the more likely it is to be approved first in Europe versus the U.S."

Shuren, however, testified that the European Commission acknowledged