The House of Representatives’ Energy and Commerce Committee has voted in favor of new legislation that would reform the way in which the US Drug Enforcement Administration (DEA) schedules new drug substances in the hopes of allowing patients to access new therapies more quickly.
The bill in question, the Improving Regulatory Transparency for New Medical Therapies Act, is meant to address a regulatory process some drug companies have described as a "black hole."
While a drug is required to be approved by the US Food and Drug Administration (FDA) in order to be marketed, the DEA must also sign off on drugs subject to the Controlled Substances Act (CSA).
The CSA, which provides for the scheduling of drugs into various classes of control, is meant to ensure that drugs that might be misused or abused aren't as readily available to consumers. For example, a drug subject to Schedule II controls might have restrictions on how many refills are available without a new prescription, and the quantity of product allowed to be prescribed at a single time.
The problem, as Focus has noted, is that DEA can take more than a year to schedule a product under the CSA, even when FDA has made specific recommendations regarding the drugs' scheduling. That delay leaves patients without access to an FDA-approved therapy and companies without the ability to market their drug.
On 12 February 2014, the House Energy and Commerce Committee approved the Improving Regulatory Transparency for New Medical Therapies Act.
The bill, as Regulatory Focus has previously explained, would require DEA to schedule drugs according to a strict timeline, giving drug manufacturers and patients more predictability.
Read our previous coverage of the bill and its provisions here.
The legislation also makes it easier to provide drugs under a clinical trial. DEA would be required to review applications to manufacture a controlled substance (Schedule III, IV or V) for use in a clinical trial within 180 days of receiving the application, and Schedule I or II drugs within 180 days, not including a notice and comment period and a 90-day application window.
The bill now awaits a vote by the full House of Representatives. If passed, the bill would be sent to the Senate, which has previously introduced companion legislation in this area.
Improving Regulatory Transparency for New Medical Therapies Act