FDA Proposes Guidelines For Compounding Pharmacies’ Ability To Make Copies Of Drugs
Meanwhile, the Food and Drug Administration commissioner calls for a more robust evaluation process for medical devices. In other news, the Cures Bill, which would have strong impact for the agency, is likely on hold until the next Congress. And, recent FDA approvals of a new heart device and drug to treat dry eye also make headlines.
STAT:
FDA Narrowly Defines The Ability Of Compounders To Make Approved Medicines
In its latest to bid to set parameters around compounding, the US Food and Drug Administration last week issued a pair of draft guidelines to clarify when compounding pharmacies are permitted to make versions of commercially available medicines. Although federal law currently states that a compounder generally shouldn’t make copies of drugs that are approved for sale, the agency is getting more specific and wants to ensure that a true clinical need exists before a compounded version of an approved medicine drug is made for a patient. (Silverman, 7/11)
Morning Consult:
Califf: FDA Needs National Evaluation System For Medical Devices
The U.S. should have a more robust national evaluation system for medical devices, Food and Drug Administration Commissioner Robert Califf wrote in an opinion article published today. A national evaluation system could “enable the FDA to focus efforts on facilitating the development and interpretation of more informative data essential for policy making and clinical decisions for individuals and populations,” Califf and Jeffrey Shuren, the director of the Center for Devices and Radiological Health at the FDA, wrote in the Journal of the American Medical Association. (McIntire, 7/11)
Stat:
Senate Delays Cures Bill, As Window For Major Legislation Narrows
Lawmakers are officially giving up hopes of considering a bill to speed the development of new medical cures before they leave town for an extended recess, sharply increasingly the likelihood that the legislation might have to be taken up by the next Congress. They’re not declaring the effort dead. Instead, Lamar Alexander, the chairman of the Senate health committee, said late Monday he hopes the Senate can reach an agreement and pass the legislation in September, when lawmakers return from a seven-week break. (Nather, 7/11)
The Wall Street Journal:
Doctors Treat First Patient With Newly Approved Heart Stent
The first significant advance in heart stents in more than a decade is providing U.S. patients and their doctors with a new option for treating blockages in the coronary arteries that cause chest pain and heart attacks. Last week, cardiologists began implanting Abbott Laboratories’ new biodegradable stent called Absorb in patients following its approval last Tuesday by the U.S. Food and Drug Administration. Unlike the permanent metal devices that have been used to prop open diseased vessels for more than 20 years, Absorb is designed to fully dissolve within two to three years after it is deployed. (Winslow, 7/11)
The Wall Street Journal:
FDA Approves Shire’s Dry-Eye Treatment
U.S. health regulators have approved Shire PLC’s dry-eye treatment, a potential blockbuster drug that is expected to go on sale in the third quarter. The drug, which would be sold under the name Xiidra, is a twice-a-day prescription eye drop solution to treat the signs and symptoms of dry eye disease in adult patients. Xiidra, or lifitegrast, which Shire added to its portfolio as part of its 2013 SARcode Bioscience acquisition, could top $1 billion a year in sales, according to some analysts’ estimates. (Armental, 7/11)
