Amid death, legitimate needs and corporate debate, FDA issues guidance on opioid painkillers

Trying to reduce the 15,000-plus annual deaths from inappropriate use of prescription opioid painkillers, the U.S. Food and Drug Administration Wednesday issued draft guidance to assist and encourage pharmaceutical companies in developing new forms of the drugs with abuse-deterrent properties.

The link to the FDA press release is here and the full guidance report is here.

Some addicts swallow too many pills. Others break or crush the pills, some snort and some liquefy the drug for injection.

FDA officials declined to say specifically what incentives might be used for companies, but they suggested valid data from rigorous clinical trials could result in specific labeling, which might give drugmakers an edge with doctors and insurers.

Officials would not discuss an ongoing dispute with Chadds Ford-based Endo Health Solutions, Inc., which wants market exclusivity for a less-crushable version of its painkiller Opana ER.

As discussed in an Inquirer story on Dec. 12 (link is here), this is an unusual situation in that Endo has sued in court and filed citizens petitions demanding that the FDA say that Endo withdrew Opana's crushable version because of safety concerns. Endo then wants its more crush-resistant version declared the new standard.

The company hopes that would then compel the FDA to stop generic versions from entering the market this year. Those versions have been approved, but do not have crush-resistant formulations.

In a conference call with reporters on Wednesday, Dr. Douglas Throckmorton, deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research, deflected several specific questions about the current Endo-generic debate.

Throckmorton was also very careful about suggesting what might be acceptable incentives for a manufacturer to conduct costly and time-consuming full-blown research and clinical trials. Past practice would suggest that drugmakers would want exclusivity, which could mean removing other forms of the drug from the market.

That happens very rarely, for while that might reduce the overdose problem among addicts, it could allow the drugmaker in that scenario to jack up the price. And addicts aside, pain medicine is used properly by millions of Americans, who would object to big price increases.

The FDA is part of the Department of Health and Human Services. FDA Commissioner Margaret Hamburg responded to a letter from Congressmen wanting to know if the FDA would pull generic versions deemed unsafe. A link to the letter is here.

"Please be assured that HHS and FDA share your concerns, and those of your constituents, regarding prescription drug abuse, including the abuse of opioid analgesics," Hamburg wrote. "HHS and FDA are committed to finding ways to reduce abuse and misuse of these medications. As part of our ongoing mission to protect public health, FDA has concluded that if FDA determines that a formulation of a product significantly deters abuse, we have legal authority, under the drug approval and drug safety provisions of the Federal Food, Drug, and Cosmetic Act, to require generic versions of that product to have abuse-deterrent formulations as well."