Posted: 21 Apr 2016 01:16 AM PDT By Michelle L. Butler & and Alan M. Kirschenbaum – The Department of Veterans Affairs (VA) recently issued an Important Notice on its website regarding a change in policy with regard to covered drugs (drugs approved via new drug applications, including authorized generics, and biologics license applications) that are not compliant with the Trade Agreements Act of 1979 (TAA). Previously, the VA required that all products offered on the Federal Supply Schedule (FSS) contract be U.S.-made or substantially transformed designated country end products. However, the VA is “now requiring that all covered drugs, regardless of county of substantial transformation, be available on a 65 I B FSS contract. In other words, we now accept covered drugs that were formally [sic] excluded due to their ‘TAA non-compliant’ nature.” As described in more detail below, the VA has set forth an aggressive timeline for companies to make these covered drugs available on the FSS contract. In making this change in policy, the VA stated that, in accordance with the Federal Acquisition Regulation, the decision has been made that contracting officers may make individual non-availability determinations regarding covered drugs so that the products can be placed on the FSS contract pursuant to: 1) information provided by the offeror that neither the offered 42-2A covered drugs nor similar or like items are manufactured in the United States or a designated country in sufficient quantity to fulfill the requirements, andThe VA has provided an aggressive timeline for these TAA non-compliant covered drugs to be added to a company’s FSS contract. In addition, for a company that does not have a 65 I B contract because it does not have any TAA-compliant covered drugs, it will be required to enter into an Interim Agreement, Master Agreement, and Pharmaceutical Pricing Agreement (this process is described here), followed by an FSS contract. The schedule for implementation is as follows:
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jueves, 21 de abril de 2016
FDA Law Blog: VA Changes Course to Require Covered Drugs that are TAA Non-Compliant to be Available on the Federal Supply Schedule
FDA Law Blog: VA Changes Course to Require Covered Drugs that are TAA Non-Compliant to be Available on the Federal Supply Schedule
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