On November 16, 2015, the House of Representatives agreed to the Senate’s amended version of the Improving Regulatory Transparency for New Medical Therapies Act (H.R. 639). We previously described how the version of H.R. 639 originally passed by the House gave manufacturers clarity and security on the timing of DEA actions related to the entrance of new drugs into the market. The Senate’s amendment maintains these provisions and then sweetens the deal, with one exception.

What’s New:  H.R. 639 allows for re-exportation among EEA countries without prior approval by DEA

Now, H.R. 639 incorporates the provisions of H.R. 2340, another bill introduced this session by Congressman Pitts. These provisions amend the Controlled Substances Import and Export Act to remove regulatory barriers to the re-exportation of controlled substances among members of the European Economic Area (the free trade zone uniting the EU member states and Iceland, Liechtenstein, and Norway) (“EEA”). The Controlled Substances Act (“CSA”) and DEA regulations currently impose conditions under which a drug in Schedule I or II or a narcotic drug in Schedule III or IV may be exported to a “first country” and then re-exported to one or more than one “second country.” If H.R. 639 becomes law, re-exportation within the EEA would change in the following ways:

• Controlled substances could continue to be re-exported among EEA countries if each exporting country and each importing country would otherwise meet the conditions required by the CSA for subsequent export from a “first country” to a “second country.”
• Within 30 days following each re-exportation within the EEA, the U.S. exporter must provide the DEA with documentation certifying that the re-exportation has occurred as well as information concerning the consignee, country, and product.
• The DEA cannot impose or enforce any regulation or policy which “impedes re-exportation of any controlled substance among [EEA] countries,” including any requirement that “information concerning the consignee, country, and product be provided prior to exportation of the controlled substance from the [US] or prior to each re-exportation among members of the [EEA].”

What’s Lost:  H.R. 639 does not allow interested parties to comment or request a hearing in response to a DEA interim final rule controlling a new drug

The Senate’s amendment to H.R. 639 eliminated the provision that allowed interested parties to initiate a proceeding regarding the DEA’s interim scheduling decision for a new drug prior to that decision becoming final. The version originally approved by the House stated that “[t]he interim final rule shall give interested persons the opportunity to comment and to request a hearing.” This version also required that such proceedings be brought to completion prior to issuance of the final rule. Now, a manufacturer must wait until the final rule is issued to appeal the controls on a new drug, and H.R. 639 does not require the DEA to do so within any certain period of time after publishing the interim final rule. However, we note Congressman Joe Pitt’s comment during Floor consideration of H.R. 639 that the DEA has not made any scheduling decision for a new drug that was contrary to the FDA recommendation since 1996. If this trend continues, interim final rules should rarely be controversial.

Like many others, we are eager for the new and improved H.R. 639 to reach the President’s desk. We will provide an update on the President’s action as soon as possible.