Medical Devices and Prescription Drug Policy

A pharmaceutical company is admitting that it marketed a drug for unapproved uses and tried to buy off doctors with golf outings and wine tastings.

On Friday, ISTA Pharmaceuticals pled guilty to conspiracy to introduce a misbranded drug and to pay illegal kickbacks for its eye drug Xibrom.

Novo Nordisk's new obesity drug could hit the American market in late 2014, adding competition as consumers and healthcare stakeholders seek to shrink U.S. waistlines.

The Danish drug company said Thursday that its injectable liraglutide treatment resulted in an average weight loss of 8 percent in a final-stage clinical trial.

The drug would cost about $25 per day, or about five times as much as rival treatments. 

Drugs with ingredients derived from starch or grain would have to disclose those materials under a new Democratic bill, the Gluten in Medicine Disclosure Act. 

Reps. Tim Ryan (D-Ohio) and Nita Lowey (D-N.Y.) introduced the measure to assist the roughly 3 million Americans with celiac disease, an autoimmune condition caused by a negative reaction to gluten.

"For millions of Americans, avoiding gluten is a medical necessity," said Lowey, top Democrat on the House Appropriations Committee, in a statement. 

A House panel on Wednesday advanced legislation along party lines to increase the tracking of prescription drugs.

The Safeguarding America's Pharmaceuticals Act of 2013 requires the Food and Drug Administration (FDA) to propose new rules to keep consumers safe from counterfeit prescriptions, but stops short of forcing regulators to finalize those rules.

Federal regulators issued the highest amount warning letters to medical device companies in 2012 than over the last seven years, according to a new study.

The federal government on Monday sought to block a judge's order requiring the agency to remove all age restrictions from the birth control pill known as Plan B.

A lower court judge struck down age limits on the sale of Plan B, saying they were driven by politics rather than science. He gave the government until Monday to seek a delay from a higher court.

The Justice Department filed a brief Monday requesting the delay, saying the lower court "plainly overstepped its authority."

Judge Edward Korman refused to delay a ruling that made the birth-control pill available to girls of all ages.

Bipartisan legislation to give federal regulators the power to track individual medication moved forward in the House on Wednesday.

A federal judge slammed the Food and Drug Administration on Tuesday over its handling of the birth-control pill known as Plan B.

Judge Edward Korman accused the FDA of putting politics above science and described its regulation of Plan B as "a lot of nonsense," according to media reports.

Korman ruled last month that the FDA must remove all age restrictions on the sale of Plan B. On Tuesday, he considered whether to stop his ruling from taking effect while the government pursues an appeal.

Individuals using tanning beds may now face some sticker shock, as federal regulators will include stronger warnings of the potential health effects.