Yesterday, “U.S. Senators Rand Paul (R-KY) and Maggie Hassan (D-NH), both members of the Health, Education, Labor, and Pensions Committee, reintroduced bipartisan legislation to streamline the approval process for generic medications, which are often significantly cheaper than their brand-name counterparts” says a release from Senator Paul’s office (here). If passed, the bill would direct the FDA to provide certain information regarding whether the Q1 and Q2 (qualitative and quantitative) formulation of the proposed generic is the same as that of the reference listed drug.
The bill entitled, Increasing Transparency in Generic Drug Applications Act (full text here), provides that the Secretary shall provide, if requested in a controlled correspondence by a sponsor prior to submission or after ANDA submission, to confirm the Q1 and Q2 nature of a formulation (and here is the potential limitation) “for a drug that is generally required by regulation or recommended in guidance to contain the same inactive ingredients in the same concentration as the listed drug referred to or for which there is a scientific justification that an in vitro approach can be used to demonstrate bioequivalence based on certain qualitative or quantitative criteria with respect to an inactive ingredient, or on the Secretary’s own initiative during the review of an application under this subsection for such a drug, the Secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug.”
Should the bill become law it would take the “Price is Right” guessing game out of these requests because the Secretary (and obviously that authority will be delegated to the FDA) would have to identify any inactive ingredient that is found not to comply to the Q1 and/or Q2 requirement and let the requestor know which ingredient and/or how it differs from the RLD. The proposed law also indicated that once the Agency makes the determination that the proposed generic is Q1 and Q2 the same, it shall not change its decision unless the Secretary determines that there was a mistake made and/or that difference in the quantity of the inactive ingredient would cause the product to be less safe or effective than the RLD.
There are also timeline provisions for the Agency to publish a draft guidance on this legislative change and seek stakeholder comments within 60 days and issue a final guidance within one (1) year from the close of the comment period. However, the provisions of the Act shall become effective on the date of enactment of the Act.
This Act, should it become law, could possibly be challenged in court because it requires FDA to essentially release what could be considered confidential commercial trade secret information, albeit, FDA has not (to my knowledge) been challenged on its release of “directional” or (as some have called it “a wink and a nod” acknowledgement) that a formulation was Q1 and Q2 which has occurred off and on by OGD since the passage of Hatch-Waxman. This Act would make life easier for the generic industry even though many products (including parenteral products which are to include on its label its formulation particulars) fail to fully follow existing requirements for generic applicants to gain the information they need to properly formulate their proposed product. It would also give the FDA additional cover to release such information. To learn more about this Q1 and Q2 issues, I refer you to these past blogs, here, here, and here.
