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Regulatory News | 21 January 2015 | By Alexander Gaffney, RAC
The House of Representatives is in the advanced stages of considering legislation that could make it easier for some drug products to reach the market after being approved by the US Food and Drug Administration (FDA).
In a notice posted to the House Energy and Commerce (E&C) Committee's website on 20 January 2015, Rep. Joe Pitts (R-PA) said he will hold a meeting on 27 January 2015 to consider several pieces of legislation, including the Improving Regulatory Transparency for New Medical Therapies Act.
As explained by Regulatory Focus last year, the bill would make changes to the US Drug Enforcement Agency's (DEA) scheduling process under the Controlled Substances Act (CSA). The 1970 law is, along with the Federal Food, Drug and Cosmetic Act of 1938, the backbone of drug regulation in the US. Specifically, the law permits DEA regulators to "schedule" drugs they believe might be misused or abused.
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. At present, even if a drug manufacturer has obtained approval from FDA to market a drug, it cannot do so without first obtaining approval from DEA as well.
The Improving Regulatory Transparency for New Medical Therapies Act wants to standardize and accelerate this process by requiring DEA to publish a scheduling decision within 60 days of FDA approving a new drug product.
According to the text of the since-revised legislation:
"Any such proceedings initiated at the request of the Secretary under this subsection to control a drug or other substance not previously scheduled, where the Secretary has recommended the drug or other substance be placed in schedule II, III, IV, or V, shall be commenced not later than 120 days after receipt of written recommendations from the Secretary. The final rule shall be issued not later than 60 days after the date on which both the public comment period has closed and the drug or other substance is the subject of an approved new drug application under section 505 of the Federal Food, Drug, and Cosmetic Act, unless a hearing on the proposed rule is granted by the Attorney General."
While that might not greatly accelerate the DEA review process for all drugs, it will at least provide a more predictable and transparent framework for drug manufacturers, who have sometimes referred to the process as a "black hole" of information, trying to get their products to patients.
The law 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.
An earlier iteration of the bill had called for substantially shorter timelines for both the scheduling process and the clinical trials process.
Two others bills, the Ensuring Patient Access to Effective Drug Enforcement Act and the National All Schedules Prescription Electronic Reporting (NASPER) Reauthorization Act, are also set to be considered by the committee's Subcommittee on Health on 27 January.
Both bills target drug abuse and drug monitoring.
E&C Meeting Notice
Focus' FDA Legislation Tracker
Tags: DEA, Drug Enforcement Administration, CSA, Controlled Substances Act, Legislation, House, Improving Regulatory Transparency for New Medical Therapies Act, Bill