FDA expects to issue nine DSCSA-related guidance documents this year, according to the agency’s just-released Guidance Agenda for 2017. While most of these are holdovers from 2016, a few are new additions. Specifically, all but the last three items below were originally slated for 2016 (see here for my post on last-year’s agenda). At least FDA can mark one of these of its to-do list. Guidance covering questions and answers related to the DSCSA’s annual reporting requirements for wholesalers and 3PLs was issued on January 10th.
- Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers
- Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier
- Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy
- Standardization of Data and Documentation Practices for Product Tracing
- Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs
- Waivers, Exceptions and Exemptions from the Requirements of Section 582 of the Federal Food, Drug and Cosmetic Act
- The Product Identifier for Human, Finished, Prescription Drugs: Question and Answers
- Identifying Trading Partners Under the Drug Supply Chain Security Act
- Fees Incurred Under the Drug Supply Chain Security Act
In addition, I’m extremely eager to see whether FDA’s guidance on verification systems will thoroughly explore what makes a product diverted or a transaction fraudulent for purposes of the DSCSA’s suspect and illegitimate product definitions. For instance, the wholesale distribution of prescription drugs, including shortage drugs, by pharmacies is typically prohibited pursuant to contractual provisions with primary wholesale distributor suppliers and should be designated by FDA in this guidance as a form of diversion, when applicable, even if such pharmacies are properly licensed to engage in wholesale distribution. Further, the wholesale distribution of discounted drugs by pharmacies in violation of own-use or closed-door pharmacy pricing arrangements with primary wholesalers should also be designated by FDA as diversion. Lastly, products diverted by pharmacies as a result of these schemes have likely been the subject of fraudulent transactions and should therefore also be considered by FDA to be suspect products under the DSCSA. It is also important to recognize that several federal criminal statues may apply to trading partners engaged in this type of diversion activity.
Unfortunately, little is being done to address the proliferation of the types of price diversion and shortage drug diversion schemes described above, but that can change. By placing a spotlight on common diversion schemes such as these in its upcoming guidance on verification systems, FDA can encourage trading partners to develop solutions designed to restrict the flow of drugs to pharmacies which have demonstrated a proclivity for engaging in such schemes.