Hearing focuses on FDA response to meningitis outbreak
WASHINGTON — Food and Drug Administration commissioner Margaret Hamburg faced strong criticism Tuesday in a hearing before the House Committee on Energy and Commerce to investigate the nationwide outbreak of fungal meningitis linked to a Massachusetts compounding pharmacy, but she conceded the agency could have done more.
"This outbreak is one of the worst public health disasters in our country’s history and is a terrible tragedy and an epic failure," the committee’s chairman, Rep. Tim Murphy, R-Pa., said in his opening remarks at the hearing, titled "A Continuing Investigation into the Fungal Meningitis Outbreak and Whether It Could Have Been Prevented." "Sadly, the [FDA], which is supposed to protect the public, has spent its time passing blame and hiding behind judicial robes rather than taking any responsibility."
To date, the outbreak has sickened 733 and resulted in 53 deaths, according to the Centers for Disease Control and Prevention. Those sickened in the outbreak were chronic pain patients who received doses of the injected steroid drug methylprednisolone acetate compounded at the Framingham, Mass.-based New England Compounding Center that was contaminated with Exserohilum rostrum, a type of mold that attacks muscle and nerve tissue, causing severe pain and, if or when it reaches the brain, death.
A subsequent investigation uncovered widespread contamination and disregard for sanitation at the NECC. The pharmacy was involved with sterile compounding, which differs from the traditional compounding used to mix medicines such as cough syrups and ointments in that it requires strict adherence to sterilization protocols and must be done in clean rooms by trained staff who wear special protective clothing. Most sterile compounded drugs are injectables, including injectable steroids like the one from the NECC, chemotherapy drugs and biotech drugs repackaged for administration in smaller doses.
"We should have more aggressively applied existing authority in spite of an ambiguous statute, a changing legal landscape and continuous challenges by industry to our authorities," Hamburg said at the hearing. "We are being more aggressive now."
Hamburg said that in the last several months, the FDA has inspected more than 50 compounding pharmacies, uncovering many practices and conditions that create the risk of contamination. Most recently, the agency investigated 31 compounding pharmacies, finding problems that warranted warnings from the agency in all but one. Still, Hamburg said, many of the pharmacies have tried to hinder the FDA’s investigations, forcing the agency in some cases to obtain federal warrants and have U.S. marshals accompany investigators.
Sandoz launches generic cardiovascular disease drug
PRINCETON, N.J. — Generic drug maker Sandoz has launched a generic version of a drug used to treat high blood pressure and angina.
The company, a subsidiary of Swiss drug maker Novartis, announced the launch of diltiazem hydrochloride extended-release capsules, a generic version of Forest Labs’ Tiazac. Sandoz is launching the drug in the 120-mg, 180-mg, 240-mg, 300-mg, 360-mg and 420-mg strengths.
Various versions of the drug had sales of about $174 million in 2012, according to IMS Health.
Changes to REMS to allow dispensing of Vivus obesity drug in retail
MOUNTAIN VIEW, Calif. — The Food and Drug Administration has approved a modification to a program added to the labeling of an obesity drug to ensure patient safety.
Vivus announced that the FDA had approved changes to the risk evaluation and mitigatin strategy for Qsymia (phentermine and topiramate) extended-release capsules. The amendment to the REMS allows the drug to be dispensed through certified retail pharmacies in addition to the existing network of mail-order pharmacies.
"With FDA approval of the REMS modification, today we begin the process of increasing the availability of Qsymia, simplifying prescribing and dispensing and resolving the challenges associated with the mail-order-only system," Vivus president Peter Tam said. "Our goal over the next three months is to ensure availability of Qsymia in thousands of certified retail pharmacies nationwide. The REMS modification is a key accomplishment in removing a major barrier that has hindered the initial acceptance of Qsymia into everyday medical practice."