President Obama recently signed the Improving Regulatory Transparency for New Medical Therapies Act into law. The Act establishes time limits for Drug Enforcement Administration (DEA) actions on determining the proper category or schedule for drugs based on their potential for abuse and offers clarity for when a medication is officially approved for purposes of calculating its exclusivity and patent terms.
A controlled substance is defined as “a drug which has been declared by federal or state law to be illegal for sale or use, but may be dispensed under a physician’s prescription.” The federal government groups these substances into five categories based on “whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused.” In 1970 the Controlled Substance Act was enacted, establishing a policy the regulation of certain narcotics, stimulants, depressants, and a number of other chemicals. The Act is implemented by the DEA, and is subject to change by the request of the FDA, HHS, DEA, or another party by submitting a petition.
In particular, the recently signed legislation amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to provide: “with respect to a [human or animal] drug [or biological product] for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the [CSA], approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with [CSA § 201(j)].”
The White House’s release further notes the Act establish time limits for the Department of Justice to make scheduling decisions; amend the covered date for extension of patent protection for drugs recommended for scheduling; revise the process for manufacturer registration of drugs for use in clinical trials; and provide for re-exportation of controlled substances across the European Economic Area.
As has been reported, the lag time between FDA approval and the DEA’s decision on scheduling a drug, and the impact on when a company can legally market a medication in the U.S., have been the subject of litigation. Eisai sued the FDA to add back time to its FDA-granted new drug exclusivity period for certain medications, because of delays in DEA actions. However, a federal district court ruled for the FDA, finding that the exclusivity period for a new drug begins when the FDA issues its letter approving the drug, even if the manufacturer must await DEA’s scheduling determination before it can bring the drug to market.
A number of stakeholders have expressed their support of the law, including bipartisan backing from members of Congress and groups like the Epilepsy Foundation.
The law will “bring much-needed certainty to the scheduling process and give patients quicker access to new therapies by setting timelines by which the DEA must schedule new drugs,” said Orrin Hatch, the Republican senator from Utah, in a statement when the Senate passed its version of the bill last month.
“Right now, patients too often have to wait for promising new treatments because of a slow and seemingly unnecessary DEA approval process,” said Sen. Sheldon Whitehouse (D-RI). “This legislation will limit the amount of time DEA has to make a decision, ensuring quicker access for patients.”
“We applaud Congress for unanimously supporting this important piece of legislation that will help bring new medications to those who so desperately need them faster,” said Phil Gattone, president and CEO of the Epilepsy Foundation. “Each new medication brings hope to those living without adequate seizure control, and it is unacceptable to allow unnecessary delays to endanger the health and well-being of these individuals.”