Hamburg called on to resign for FDA's approval of Zohydro

FDA Commissioner Margaret Hamburg--FiercePharma file photo
FDA Commissioner Margaret Hamburg

The FDA approved opioid painkiller Zohydro nearly a year ago as a med to provide relief for those with chronic pain. But the drug has been nothing but 11 months of aggravation for the agency and its leader, Commissioner Margaret Hamburg, who is now being called on to resign by organized anti-addiction groups who say the FDA has contributed to an epidemic of abuse in the country.

"We are especially frustrated by the FDA's continued approval of new, dangerous, high-dose opioid analgesics that are fueling high rates of addiction and overdose deaths," says a letter to Hamburg's boss, Health and Human Services Secretary Sylvia Burwell, according to CBS News. The letter is signed by about 15 groups.

An HHS spokesperson said Burwell would respond, adding that opioid abuse "is a serious issue and one that the secretary is focused on."

The approval of Zohydro and other painkillers has turned into a political hot potato for Hamburg, who has pointed out that 100 million people who suffer from chronic pain are looking for relief. But some doctors, prosecutors and politicians have pointed to rising rates of opioid addiction and overdose deaths, and the attendant crime, and called on the agency to stop approving new drugs in the category. Overdose deaths from painkillers tripled in the 20 years leading up to 2011.

The groups claim the agency is not in sync with a country overwhelmed by a drug problem and point to the U.S. Centers for Disease Control and Prevention (CDC) recommendation that doctors reserve high-powered painkillers for use on cancer patients and for end-of-life care. Most prescriptions are written, instead, for back pain and arthritis.

The letters says, "Dr. Hamburg's support for using opioids to treat chronic non-cancer pain is squarely at odds with efforts by the CDC to discourage this widespread practice." But FDA spokeswoman Erica Jefferson responded that "[p]reventing prescription opioid abuse and ensuring that patients have access to appropriate treatments for pain are both top public health priorities for the FDA."

In testimony this year before a Senate committee, Hamburg said, "We recognize that this is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy." The FDA has also approved some drugs that are formulated in ways to make them more difficult to abuse, but Hamburg has also acknowledged that abuse-deterrent technology so far has been unable to foil dedicated abusers.

The approval last October of Zohydro, the first extended-release uncut form of hydrocodone, provided a rallying point for building frustration. The issue has also been a media magnet for some politicians, like Massachusetts Gov. Deval Patrick, who drew national attention for his failed effort to ban its use in Massachusetts.

The companies that make some of the most abused painkillers have also come in for criticism and, more recently, legal action. The city of Chicago and two California counties have filed lawsuits against 5 manufacturers of prescription painkillers, accusing them of conspiracy and fraud in an effort to alter public perceptions about narcotic painkillers. The suits are seeking millions of dollars to pay for the public's costs. The 5 companies include Actavis ($ACT), Endo ($ENDP), Johnson & Johnson's ($JNJ) Janssen Pharmaceuticals, Purdue Pharma and Teva ($TEVA).

- here's the CBS story