Republicans commend FDA for guidelines on tamper-proof drugs

“They can be swallowed whole, crushed and swallowed, crushed and snorted, crushed and smoked, or crushed, dissolved and injected,” reads an excerpt of the document, which calls for the use of recipes that block feelings of euphoria and outer shells that make crushing the pills difficult.

ADVERTISEMENT
House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) and Sen. Tom Coburn (R-Okla.) applauded the agency for meeting a Wednesday deadline for the guidance, set forth in the Food and Drug Administration Safety and Innovation Act of 2012.

“The draft guidance represents an important step forward in understanding how the FDA will apply the science of abuse deterrence,” the lawmakers said in a joint statement.

National Drug Control Policy Director Gil Kerlikowske called the action a vital piece of the Obama administration's effort to curb a “prescription drug abuse epidemic” in America.

“While there are no silver bullet solutions to this public health and safety challenge, abuse-deterrent formulations of powerful prescription opioids can make a difference in addressing this epidemic,” Kerlikowske said.

The action failed to impress former Rep. Mary Bono Mack (R-Calif.), however, who served as co-chairwoman of the Congressional Caucus on Prescription Drug Abuse before she was defeated in November.

Bono Mack described the nonbinding FDA recommendations as “lip service,” saying more definitive action is needed.

“They gloss over the problem,” she said. “It’s not enough.”

The FDA is seeking public comment on the guidelines over the next 60 days.