''FDA sees huge opportunities in opening up drug data''

National Public Health Week

''Let The Sunshine In: CMS Releases Transparency Rule''

"After 15 months of delay, the Centers for Medicare & Medicaid Services has finally released the long-awaited Sunshine Act rule, which establishes procedures for gathering and publishing data containing financial ties between physicians, teaching hospitals and drug and device makers, as well as group purchasing organizations."

Letter From Pew and Medtronic to HHS Regarding the Physician Payments Sunshine Act

The Pew Health Group and Medtronic, Inc. file a joint letter to the U.S. Department of Health and Human Services urging implementation of the Physician Payments Sunshine Provision, which will require that manufacturers of drugs, devices,biologics or medical supplies report to the agency payments made to physicians and teaching hospitals.

Test Your Knowledge of Antibiotics

Nearly nine in 10 Americans recognize that antibiotics are effective treatments for fighting bacterial infections like strep throat, but more than a third mistakenly believe the drugs are also appropriate treatments for viral infections such as the common cold. Test your antibiotics IQ and take the quiz.

''Report Says FDA Needs Workforce Improvements''

In 2007, an agency panel found that the FDA’s "scientific workforce does not have sufficient capacity and capability" and the agency is "not positioned to meet current or emerging regulatory responsibilities." The Pew Charitable Trusts wanted to know if that’s still the case, and asked the Partnership for Public Service to find out. "FDA has made progress," says the Partnership’s report, but the agency "continues to have significant workforce and management challenges in the scientific and medical arenas that need to be addressed."

''FDA Stakeholders Worry About Sequestration''

"Representatives from the FDA and industry expressed serious concerns about the potential impact of sequestration Monday, saying it's not a good time to shortchange the agency when it's under so much pressure to help bring innovative new drugs to market."

''Report: State Prescription Monitoring Programs Falling Short''

"Forty-nine states, including Maine, now operate a prescription monitoring program - or are putting one in place - to track the powerful pain medication dispensed by pharmacies. These databases have already helped in the fight to curtail diversion and abuse of prescribed opioids. But the way they operate - and how the data they collect gets used - varies widely from state to state."

A Healthy Dose of Bipartisanship

Passed by Congress on June 26 and signed by President Obama on July 9, the FDA Safety and Innovation Act will increase inspections of foreign manufacturers that supply 80 percent of the ingredients in our pharmaceuticals, putting American companies on the same footing as their foreign competitors. In addition, it requires drug makers to hold their suppliers to high standards.

''Drug, device reform gets bipartisan push''

"The U.S. Supreme Court's eagerly awaited Affordable Care Act ruling unfortunately overshadowed the unusually bipartisan work underway at the U.S. Capitol last week, where Congress finalized sweeping legislation crammed with smaller-scale but still vital health reforms."

''FDA Probing Safety of Metal-on-Metal Hip Implants''

"While thousands of Americans have benefited from hip replacements over the years, problems with metal-on-metal implants can lead to troubles requiring surgery to replace defective devices, experts say. Writing earlier this month in the New England Journal of Medicine, Pew's Joshua Rising and colleagues said that "there is now compelling evidence that these implants fail at a higher rate than hip prostheses made of other materials."

Pew Commends Congress for Passing FDA User Fee Legislation

The U.S. Senate today joined the House in passing Food and Drug Administration Safety and Innovation Act (S. 3187), a bill to support the U.S. Food and Drug Administration’s drug and device reviews. The bill now goes to President Obama to be signed and implemented.

''FDA user fee bill gives agency new powers to inspect overseas prescription drug plants''

"A Food and Drug Administration bill designed to increase inspections of foreign drug factories, while also speeding approvals of new drugs at home, is headed to the president’s desk after an overwhelming approval in the U.S. Senate."

''Disclosure can address doctors' conflicts of interest''

Pew Prescription Project Director Daniel Carlat opines in the Philadelphia Inquirer: "Monetary relationships among doctors and drug and device companies are not inherently bad; in fact, they are crucial for advancing medical research and patient care. Yet they can also skew prescribing practices and research results. That's why transparency and education are such an elegant solution: They allow these often important relationships to exist, but only on the condition that other professionals and patients are fully informed about them."

Facilitating Medical Device Innovation: De Novo Reform

Improving Medical Device Safety Through Better Surveillance

In 2008, the Food and Drug Administration (FDA) launched the Sentinel Initiative, a national electronic system designed to “track the safety of drugs, biologics, and medical devices once they reach the market.” By proactively monitoring data from electronic health records and other sources rather than relying on spontaneous reporting from manufacturers and health care providers, the Sentinel system can more quickly identify safety issues.