Morning Briefing

Stat: FDA Official Hints At A Tough Road Ahead For ‘Right To Try’ 

A top Food and Drug Administration official seemed to suggest that the new “right-to-try” law, which skirts around the FDA’s traditional authority to help patients get access to unapproved therapies, might have harmful consequences. Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, said the agency’s experience with stem cell clinics might foreshadow its future with right to try. He pointed to some clinics that purported to treat patients for a variety of conditions and instead ended up blinding them or causing tumors. (Swetlitz, 11/14)

San Jose Mercury News: FDA Recalls Another Blood Pressure Medication

For the third time this year, the FDA is recalling a blood pressure medication due to a carcinogenic contaminant in the drug that might cause cancer. Get ready to check the medicine cabinet for losartan potassium hydrochlorothiazide tablets made by Sandoz because the pills may contain an impurity, N-nitrosodiethylamine (NDEA), the FDA reports. This substance is a probable human carcinogen, according to the International Agency for Research on Cancer. While other companies also manufacture this medication, only the Sandoz lot is being recalled. (D'Souza, 11/14)

The Washington Post: ‘Rapid Release’ Tylenol Gelcaps Are Slower To Dissolve Than Cheaper Tablets, Study Finds

The Extra Strength Tylenol “Rapid Release gels” package depicts a blue-and-red capsule gushing a cloud of pain-relieving medicine from laser-drilled holes, a visual depiction of relief. But the gels actually dissolved more slowly than less expensive Tylenol tablets in a laboratory test, according to a study published in the journal Advances in Investigational Pharmacology and Therapeutic Medicine — with the rapid-release gelcaps taking about 30 seconds longer than a tablet of the same dose. The researchers from Valisure, a start-up pharmacy that screens medicines, found a similar effect when they compared rapid-release gelcaps to regular tablets of generic acetaminophen from Walgreens, Rite Aid and Walmart Equate. (Johnson, 11/14)

The Wall Street Journal: Ginkgo Supplement Was Ginkgo-Free, U.S. Watchdog Finds

Two dietary supplements promoted as improving memory using Ginkgo biloba contained either none of the ingredient or a lower amount than advertised, a government watchdog said Wednesday. The products tested for Ginkgo biloba—the plant species commonly known as the ginkgo or maidenhair tree—contained other, unknown ingredients instead, according to a report by the U.S. Government Accountability Office. Because it couldn’t identify those ingredients, “the safety of the substitute ingredients could not be determined by the laboratory,” the GAO said. (Hopkins, 11/14)

Pfizer lost the final round in a long-running patent battle in Britain on Wednesday after the country's highest court ruled against it in a case involving its $5 billion-a-year pain drug Lyrica. The Supreme Court decision is a blow for the U.S. drugmaker -- which had sought to affirm a secondary medical use patent for the product -- and a win for generic drug companies Actavis, now renamed Allergan, and Mylan. (Hirschler, 11/14)