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Morning Read: GAO reports critical of FDA’s drug approval process add support to regulatory reform argument

Also, the market for biometric sensors is expected to reach $1.83 billion by 2024, a report criticizes American Red Cross’ financial accountability, and there are seven drugs in advanced testing to combat superbugs.

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The Government Accountability Office has issued two reports critical of the U.S. Food and Drug Administration’s approach to approving drugs and devices. One report, titled “FDA Needs More Strategic Planning to Guide Its Scientific Initiatives,” said the regulator lacks measurable goals to assess its progress in advancing the science supporting its effort to assess the products it regulates. The second report is “Comprehensive Strategic Planning Needed to Enhance Coordination between Medical Product Centers.”  Republicans view the report as providing plenty of ammunition to speed up drug approval as part of the 21st Century Cures bill. — GAO report one, GAO report two, STAT

LIFE SCIENCES

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Richard J. Hatchett, acting director of the government’s biodefense agency, Biomedical Advanced Research and Development Authority, told a House subcommittee hearing that thanks to federal initiatives, there are seven drugs in advanced testing that are designed to combat Gram-negative bacteria which produce superbugs. — The Wall Street Journal

Rgenix raised $33 million in a series B round led by new investors Novo A/S (Hellerup, Denmark) and Sofinnova Partners to support its lead cancer immunotherapy treatment, expected to enter clinical trials this fall. Existing investors also taking part in the round include Partnership Fund for New York City, Alexandria Venture Investments and Conegliano Ventures. — Bio-IT World

PAYERS-PROVIDERS

Unlike the steady stream of losses reported by payers blaming the Affordable Care Act for their downturns, Blue Cross Blue Shield of Florida had a profit of $471 million on ACA individual plans. It views the retail centers, which give customers one-on-one enrollment help and its high-deductible plans as key to its profit. But it still plans to jack up premium rates at 9.8% for individual plans and 8.7% for small-group plans 9.5% to 16.5% for its HMO network. — Modern Healthcare

More healthcare consolidation: Envision Healthcare and AmSurg merge. The deal makes good on contract physician company AmSurg’s desire to get larger, creating one of the biggest providers of specialty physicians. — Bloomberg

Two pharmaceutical salesmen were arrested over charges that they paid New York doctors a total of $259,000 to prescribe the opioid fentanyl. The salesmen  worked for Arizona-based Insys Therapeutics. Its FDA approved product Subsys, is a fast-acting form of fentanyl. These kind of kickback schemes are helping to drive up the number of unnecessary opioid prescriptions. More than 14,000 died from prescription opioid overdoses in 2014.— USA Today

Hospitals are no strangers to social media and their presence seems to be growing. Here are 10 hospitals using Instagram. —Health Care Communication News

TECHNOLOGY

The market for biometric sensors is expected to reach $1.83 billion by 2024, according to a report by Grand View Research. — PR Newswire

POLITICS

Iowa Sen. Chuck Grassley has published a report critical of American Red Cross finances after a year-long investigation of the charity. — NPR

A LITTLE BIT EXTRA

Happily, the World Health Organization has walked away from the claim that coffee causes cancer –more specifically it said, “(This) does not show that coffee is certainly safe … but there is less reason for concern today than there was before,” according to Dana Loomis, a deputy head of the International Agency for Research at a news conference. But don’t worry sanctimonious tea drinkers, it still believes hot coffee poses a threat by increasing the risk of getting cancer of the esophagus. — Reuters

Photo: Flickr user Charles Williams

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