House panel to vote on drug rules, autism research

The House Energy and Commerce Committee plans to vote next week on legislation dealing with prescription drug abuse and federal funding for autism research.

One of the bills, H.R. 4299, would require the Drug Enforcement Agency (DEA) to schedule prescription drugs with potential for abuse within 45 days of being approved by the Food and Drug Administration, and finalize the scheduling within 180 days.


The DEA ranks drugs based on their potential for abuse into five categories from Schedule I to Schedule V. Moving hydrocodone from a Schedule III to Schedule II would further restrict who can prescribe the drug and how much of the drug patients would have access to at any given time.

Last year the FDA approved Zogenix’s controversial painkiller Zohydro ER, which is made of pure hydrocodone. At the time, the agency recommended all hydrocodone products be moved from Schedule III to Schedule II to further limit access to such drugs because of their high potential for abuse.

However, the DEA has still not finalized the rescheduling.

“The existing delays are the result of a flaw in the Controlled Substances Act, which requires new FDA-approved medicines with the potential for abuse to undergo a controlled substance ‘scheduling’ by the DEA before they can be marketed,” said Philip Gattone, CEO of the Epilepsy Foundation and a proponent of the House bill. “Access to new therapies is particularly important for the 20 to 30 percent of people living with epilepsy who experience intractable or uncontrolled seizures or have significant adverse effects to existing medicines.”

Another bill up for consideration, H.R. 4709, would require makers of abused drugs and their distributors to register with the DEA to ensure criminal background checks of their employees. It would also create a Combating Prescription Drug Abuse working group of public law enforcement and private stakeholders to find ways to reduce prescription drug abuse.

One provision in the bill would give pharmacies that have in some way violated the DEA’s rules the opportunity to try correct their mistakes before the agency suspends their license to practice.

Besides the prescription drug bills, the House committee will also take up H.R. 4631, which would continue federal funding for autism research.