Scott Gottlieb vows to shake up the FDA, backing a trend toward faster drug development

Scott Gottlieb vows to shake up the FDA, backing a trend toward faster drug development-endpointnews: FDA commissioner Scott Gottlieb has sounded a crystal clear warning over the high — and growing — cost of drug development. And in a speech to regulatory execs on Monday, Gottlieb committed the FDA to backing up more efficient drug development programs with new measures to clear the regulatory path for developers barreling ahead to relatively swift pivotal data in search of an accelerated OK.

Long-stalled FDA reform sits on Senate’s lame-duck calendar

Long-stalled FDA reform sits on Senate’s lame-duck calendar-washingtonpost: Republicans in Congress are pushing to pass long-stalled legislation by December that gives the Food and Drug Administration new powers to more rapidly approve drugs and medical devices.

Former commissioners: Make FDA an independent agency

Former commissioners: Make FDA an independent agency- politico: Six former Food and Drug Administration commissioners from Democratic and GOP administrations dating back to the Reagan era today called on Congress to make the agency independent, raising its profile and power by taking it out from under the umbrella of the Department of Health and Human Services.

FDA releases 180-day PMA memos

FDA releases 180-day PMA memos-massdevice.com:
The FDA's Center for Devices & Radiological Health releases a smattering of summary review memos of 180-day design changes to medical devices that have already won a green light from the federal watchdog agency

MDUFMA: Shuren, Burr renew hostilities over FDA's medical device reviews

MDUFMA: Shuren, Burr renew hostilities over FDA's medical device reviews-massdevice.com:

The FDA was back on Capitol Hill Thursday, selling the benefits of its $600 million promise to the medical device industry to get better, the same day that a GAO report called the watchdog agency out on being "inconsistent" in its reviews of complex medical devices.

GAO: FDA "inconsistent" in meeting performance goals

GAO: FDA "inconsistent" in meeting performance goals-massdevice.com:

The FDA met most performance goals between 2003 and 2010, but was inconsistent in its review of pre-market approval applications, especially those marked "expedited," according to a Government Accountability Office report.

Device trials- more women needed

Device trials- more women needed- massdevice.com: The FDA is considering a new, non-binding guidance that would encourage companies to include more women in their medical device clinical trials. A new article in the Journal of the American Medical Association by Sanket Dhruva and Rita Redberg of the University of California at San Francisco offers this example to show its necessity:

Republican senators grill FDA medical device chief Dr. Jeffrey Shuren

Republican senators grill FDA medical device chief Dr. Jeffrey Shuren-massdevice.com:FDA Center for Devices & Radiological Health chief Dr. Jeffrey Shuren got pummeled by Republican members of the Senate Health, Education, Labor & Pensions committee this week.

More Than 40 Lawmakers Urge FDA To Overhaul Device Review Policies

More Than 40 Lawmakers Urge FDA To Overhaul Device Review Policies- Gray Sheet:

A slew of lawmakers in both chambers are advocating major changes to FDA device reviews, with the group urging the agency to embrace a “least burdensome” approach that involves tracking device approvals in real time, harmonizing requirements with international standards, addressing new conflict-of interest rules and creating a product review tracking system, among other changes. These proposals, many of which are already tucked into pending legislation, are expected to take center stage when Congress considers reauthorizing the device user fee program next year, with lawmakers for months already raising device-related concerns.
These ideas have been included in recent bills or proposals from key lawmakers, including members of the House Energy and Commerce Committee and Senate health panel. Sen. Richard Burr (R-NC), for example, has pushed for FDA review times to include periods when firms are answering agency questions and for the clock not to pause, while Rep. Michael Burgess (R-TX) has drafted legislation to repeal advisory committee conflict of interest rules implemented as part of the last iteration of user fees.
The device industry has long argued that it faces unclear and overly burdensome device review requirements, but recent data suggest that those concerns have merit, according to the lawmakers, who pointed to information demonstrating that 510(k) review times increased 43 percent from the 2003-2007 time period to 2010, with premarket approval times jumping 75 percent.
The lawmakers -- members of the Congressional Medical Technology Caucus -- even leveraged a recent report issued by the Obama administration's Jobs Council outlining the declining investment in life sciences due to increased development costs and risk.
“Increased review times, inconsistent expectations, and poor communication from the FDA are causing a lack of confidence and instability in the industry,” the lawmakers wrote in a letter to FDA Commissioner Margaret Hamburg. “The total review times for both 510(k)s and PMAs are now actually longer than they were before the user fee program was instituted. … Unless we make significant improvements to the predictability and transparency of the regulatory process, we will lose the industry, the jobs that go with it, and the innovation to transform our healthcare system.”
Signatories of the recent letter include Sens. Dick Lugar (R-IN), Al Franken (D-MN), Amy Klobuchar (D-MI) and Scott Brown (R-MA), and Reps. Anna Eshoo (D-CA), Erik Paulsen (R-MN), Burgess, Michele Bachmann (R-MN) and Jan Inslee (D-WA). In sum, 41 lawmakers signed the letter, which was also sent to HHS Secretary Kathleen Seblius. -- Ben Moscovitch ( bmoscovitch@iwpnews.com This e-mail address is being protected from spambots. You need JavaScript enabled to view it )

FDA Overrules Staff Analysis in Approving Anticlotting Drug-wsj.com

FDA Overrules Staff Analysis in Approving Anticlotting Drug-wsj.com: The Food and Drug Administration on Friday approved the latest in a class of new anticlotting drugs to prevent stroke—Xarelto from Johnson & Johnson and Bayer AG—but overruled its own staff's analysis in doing so.

Venture capitalists, trying to curb health-care costs-washingtonpost.com:

Venture capitalists, trying to curb health-care costs-washingtonpost.com: Over the past two decades, venture capitalists helped make possible striking advances in health care, including robotic surgery, cancer vaccines and genomics. But such innovations also fuel higher health-care spending, and now private investors see new opportunities in betting on companies that could curb those costs.