First 3-D Prescription Drug OK’d By FDA
The Food and Drug Administration approved the first three-dimensional printed drug -- a medication to treat seizures. Elsewhere, statistics on medical scope safety are called "outdated," rules on e-cigarettes lag and medical marijuana legislation stalls.
The Associated Press:
FDA Clears First 3-D Printed Prescription Drug
The Food and Drug Administration has approved the first prescription drug made through 3-D printing: a dissolvable tablet that treats seizures. Aprecia Pharmaceuticals said Monday the FDA approved its drug Spritam for adults and children who suffer from certain types of seizures caused by epilepsy. The tablet is manufactured in a layered process via 3-D printing and dissolves when taken with liquid. (8/3)
Los Angeles Times:
Statistic On Safety Of Medical Scopes 'Inaccurate, Outdated,' Researchers Say
For decades, doctors reassured patients about the safety of medical scopes with a single statistic. ... The estimate — that the risk of getting a serious infection from an endoscope is just 1 in 1.8 million procedures — brought relief. It implied that the danger was virtually nonexistent. But the statistic is 22 years old. And even then it was wrong. (Petersen, 8/4)
CQ Healthbeat:
Wait Continues For FDA Rule On E-Cigarettes
A proposal to give the Food and Drug Administration authority to police electronic cigarettes and other unregulated tobacco products remains in limbo more than a year after it was first released and a month after the agency estimated it would be published.
Health and Human Services Secretary Sylvia Mathews Burwell told a Senate panel in April that the administration hoped to finalize the so-called deeming rule this summer and there is still time to meet that goal. She dialed back the tone during a House hearing last week, saying she hopes the rule will emerge “as quickly as possible.” (Attias, 8/3)
CQ Healthbeat:
Pot Bills Stalled Despite Increased Support
Even though Senate support for a medical marijuana bill is building, it’s not getting the backing it needs to advance. Two influential Democratic senators, Charles E. Schumer of New York and Barbara A. Mikulski of Maryland, announced their support for the bill that would reschedule marijuana and let states set medical marijuana policy. But it needs more Republicans. (Fleming, 8/3)
