It may be Valentine's Day in the US, but it's safe to say that some of the Senate's most prominent members don't love a decision recently made by the US Food and Drug Administration (FDA).
On 12 February 2014, Sens. Mitch McConnell (R-KY), Tom Coburn (R-OK) and Lamar Alexander (R-TN) wrote to FDA Commissioner Margaret Hamburg demanding answers and "accountability" for the agency's October 2013 decision to approve Zohydro, a pure hydrocodone product.
The decision to approve the product was seen by many as surprising, as the drug, indicated for the management of severe pain for which alternative treatment options are inadequate, lacked the abuse-deterrent qualities present in many of its alternatives.
Hydrocodone is already associated with an epidemic of abuse in some parts of the country, and the agency has routinely touted its efforts to clamp down on the abuse of the drug. For example, it has asked the Drug Enforcement Agency (DEA) to reschedule hydrocodone to a Schedule II medication under the Controlled Substances Act (CSA).
It was also surprising given an overwhelming vote (11-2) by an FDA advisory committee against Zohydro in late 2012. While FDA is not obligated to follow the advice of its advisory committees, it usually does, especially in cases where the intent of the committee is unambiguous.
At the time of approval, FDA said the drug, based on its risk of addiction and abuse, should be "reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain."
Zohydro was also given stronger warnings, and is a Schedule II medication under the CSA, meaning physicians cannot prescribe a drug with automatic refills. However, despite its approved indications, doctors could still prescribe it off-label for a variety of unapproved indications.
But as the senators explain in their report, it's not the approved indication that has them worried-it's the potential for abuse and misuse.
"In 2010, drug overdose was the leading cause of injury-related death in the United States, largely driven by opioids," they wrote. "Data from the Centers for Disease Control and Prevention (CDC) show that more than 16,000 Americans die from opioid drug overdoses each year," of which approximately 75% are attributable to opioid analgesics.
And given the "clear warning" from FDA's Analgesic Drug Products Advisory Committee that the drug, lacking abuse-deterrent qualities, would be associated with higher rates of abuse, the senators said they were perplexed why it was ever approved.
"This decision contradicts FDA's own advisory panel, and could undermine the important measures taken by FDA lawmakers and state attorneys general to curb prescription drug abuse across the country unless accompanied by appropriate safeguards and due consideration for the potential for abuse," they wrote.
In addition to the legislators' more general concerns, they asked Hamburg to explain how FDA weighs the risk of abuse, misuse and diversion in its regulatory decision making.
They also pressed Hamburg to explain how FDA plans to exercise its legal authority to require some medications to have abuse-deterrent qualities, which she confirmed in a 2013 letter to the legislators and to a more limited extent in a 2013 draft guidance intended to incentivize the development of abuse-deterrent qualities. FDA has, however, allowed the sale of at least one generic version of a non-abuse-resistant generic version of Opana ER (oxymorphone hydrochloride), an opioid painkiller.
As The Pink Sheet notes, the letter comes just one month before the product is expected to be sold.
McConnell Letter to FDA