By Karla L. Palmer –
Late last week, Senators Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI), both members of the Senate Committee on Health, Education, Labor, & Pensions, announced the introduction of S. 2862, the “Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act.” The legislation seeks to “streamline” and “increase transparency in the approval process” for controlled substances by creating a specific timeline for DEA to schedule certain controlled substances that have never before been marketed in the United States. In March 2014, a somewhat similar bill was introduced in the House of Representatives (H.R. 4299; see our previous post here), also addressing the need for DEA to act promptly in making scheduling decisions for newly approved drugs.
The prompt scheduling provisions of the legislation are the fallout of DEA’s very public delay in scheduling a drug subject to an exclusivity period (FYCOMPA™). The delay prompted Eisai to first file a petition for a writ of mandamus requiring DEA to make a scheduling decision so the drug could be marketed, and then to sue FDA (see our previous posts here and here).
The bi-partisan bill seeks the following:
- Amend the CSA to require that DEA schedule a drug or substance that has never been marketed in the United States within 45 days of receiving a scheduling recommendation from the Secretary of HHS. This proposed provision is identical to H.R. 4299.
- Hasten the development of new drug therapies by allowing researchers to indicate on their DEA application that the controlled substance will only be used for clinical trials of a drug. This proposed provision is also identical to H.R. 4299.
The following provisions are not included in previously introduced H.R. 4299:
- Clarify terminology in the CSA for the terms: “consistent with the public health and safety” and “imminent danger,” which, Senator Hatch claims, will “improve the ability of the DEA to work collaboratively with distributors and other stakeholders to prevent drug diversion.” This change would define the statutory term “imminent danger” as follows: In the “absence of an immediate suspension order, controlled substances will continue to be distributed or dispensed by a registrant who knows or should know . . . or has reason to believe that (A) the dispensing is outside the usual course of professional practice; (B) the distribution or dispensing poses a present or foreseeable risk of adverse health consequences or death due to the abuse or misuse of the controlled substances; or (C) the controlled substances will continue to be diverted outside of legitimate distribution channels.” Note the “imminent danger” standard has recently been challenged in at least three DEA matters. See Holiday CVS v. Holder, (Civ. No. 12-191) (D.D.C. Mem. Op. Mar. 16, 2012); Cardinal Health v. Holder (Civ. No 12-185) (D.D.C. Mem. Op. Mar. 7. 2012); Walgreen Company v. DEA (Civ. No. 12-1397) (D.C. Cir., filed Oct. 10, 2012).
- Amend 21 U.S.C. § 824 (Denial, revocation or suspension of registration) to allow registrants who face having their registration revoked or suspended pursuant to an order to show cause the opportunity to submit a corrective action plan within the time period set forth in the order (not less than 30 days). Registrants subject to an immediate suspension order shall not be entitled to submit a corrective action plan, however.
- Require the Secretary of Health and Human Services – not later than one year after enactment – to submit a report to Congress assessing how enforcement activities may affect patient access to needed medications; issues with diversion; and identify how collaboration between agencies and stakeholders can benefit patients and prevent prescription drug abuse. This section of the legislation requires collaboration among FDA, Centers for Disease Control and Prevention, DEA, and Office of National Drug Control Policy. The report will require feedback from patient groups, pharmacies, drug manufacturers, common and contract carriers, hospitals, state attorneys general, law enforcement, insurance providers, and drug distributors.