Congress To Vote On Prescription Drug Abuse Bill

Congress has announced that they will soon vote on bill H. R. 4299, which centers on curbing prescription drug abuse. H. R. 4299 would directly affect pharmaceutical companies, as it would require the Drug Enforcement Agency to begin the scheduling process for prescription drugs with the potential for abuse within 45 days of the drugs’ approval by the Food and Drug Administration. The drug scheduling process must be finalized within 180 days.

This scheduling can affect what classification the drug is assigned to. The placement of a particular drug into any given category can make the drug more difficult to access. Schedule I drugs are the most difficult to gain access to, while Schedule V drugs are the least restricted. The most notable example of this process occurred last year when the FDA’s scheduled Zogenix’s Zohydro ER painkiller. The FDA made a recommendation that all hydrocodone based products be moved from Schedule III to Schedule II, as hydrocodone based products have a high potential for drug abuse.

Various groups have spoken up in regards to H. R. 4299 and the drug scheduling process. “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.”