FDA

FDA Moves To Rein In Drugmakers' Abuse Of Orphan Drug Law

Sep 13, 2017

The Food and Drug Administration is changing the way it approves medicines known as "orphan drugs" after revelations that drugmakers may be abusing a law intended to help patients with rare diseases.

Matt Markgraf, WKMS

Members of the Kentucky Tobacco Research Board are considering potential future uses for burley and dark leaf tobacco grown in the bluegrass state. Discussion at Monday’s meeting addressed proposed FDA regulation of nicotine levels in tobacco products.

The Food and Drug Administration is cracking down on "unscrupulous" clinics selling unproven and potentially dangerous treatments involving stem cells.

Hundreds of clinics around the country have started selling stem cell therapies that supposedly use stem cells but have not been approved as safe and effective by the FDA, according to the agency.

Given the fact that "New of Kopi Jantan Tradisional Natural Herbs Coffee" has been marketed as a "male enhancement" product, it might be fair to assume that consumers who plucked the instant coffee off store shelves had a clear idea of its intended effects.

Jonas Bergsten, Wikimedia Commons, Public Domain

Hearing aids are expensive, but there could be cheaper options. That’s according to findings from a new study by Johns Hopkins School of Medicine.

Matt Markgraf, WKMS

The Food and Drug Administration’s first proposed regulation related to smokeless tobacco is getting attention from agriculture and health officials in Kentucky. 

The Food and Drug Administration requested Thursday that the drugmaker Endo Pharmaceuticals stop selling Opana ER — its extended-release version of Opana.

The FDA says the move marks the first time the agency has taken steps to remove an opioid from the market because of "public health consequences of abuse."

The Food and Drug Administration is under pressure from the Trump administration to approve drugs faster, but researchers at the Yale School of Medicine found that nearly a third of those approved from 2001 through 2010 had major safety issues years after the medications were made widely available to patients.

The Food and Drug Administration says children under 12 should not be given prescription medicines that contain codeine or another narcotic, tramadol, and that such drugs can also be dangerous to youth between 12 and 18.

With the approval this month of two drugs to treat hepatitis C in children, these often overlooked victims of the opioid epidemic now have a better chance at a cure. Kids may actually have an easier time than adults getting approved for the treatment, according to some health policy specialists.

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