Mark Mansour, Partner, Bryan Cave, LLP
Recession, Reform Efforts Put Pressure On MedTech Venture Funding Model
A recent report by Ernst & Young has found that the economic recession, along with health care reform and the changing regulatory and reimbursement environment are putting pressure on the traditional medtech venture capital funding model. The report notes that funding is down 59 percent in 2009 and that hurdles, such as the prospect of changes to the 501(k) program that might increase the time, cost, and risk in receiving FDA clearance, and reimbursement uncertainty, are further putting pressure on access to financing.
FDA Requests Comments On Administrative Detention and Banned Medical Devices
The FDA has announced that it is seeking comments on its administrative detention and banned medical devices procedures. Comments are due by December 15, 2009. More information is available at http://edocket.access.gpo.gov/2009/E9-24921.htm.
FDA: P&G Warning Was in Error
The FDA has stated that the warning letter to Procter & Gamble posted on its website, in which it stated that the company wrongfully added Vitamin C to its Vicks cold formulas, was never issued and was erroneously posted.
FDA Launches Web Page Listing Disposal Instructions for Select Medicines
The FDA has launched a Web page for consumers with information on how to dispose of certain drugs, including several high-potency opioids and other selected controlled substances. The FDA recommends that these medicines be disposed of by flushing down the sink or toilet. More information is available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186598.htm.
On this effort, the FDA worked with the White House Office of National Drug Control Policy (ONDCP) to develop the first consumer guidance for proper disposal of prescription drugs. The ONDCP federal guidelines were first issued in February 2007. The 2009 version of the federal guidelines is available at http://www.whitehousedrugpolicy.gov/publications/pdf/prescrip_disposal.pdf.
CDRH Acting Director Jeffrey Shuren Vies For Permanent Spot
Acting device center director Jeffrey Shuren announced his candidacy to agency staff last week, according to Principal Deputy FDA Commissioner Joshua Sharfstein. The tone surrounding his candidacy is a positive one, with Sharfstein giving Shuren a mandate from Hamburg to move forward aggressively on key priorities. Shuren announced six of these priorities last month, which include reviewing the 510(k) pre-market notification program, learning how FDA can adapt to changing technology while providing a predictable regulatory pathway, and establishing clear procedures for resolving differences of opinion within the center.
Mark Mansour is a partner in the firm, Bryan Cave, LLP
