The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers” (Proposed Rule)—pursuant to FDA’s obligations under the Drug Supply Chain Security Act (DSCSA or the Act) that, when finalized, would require all US wholesale drug distributors (WDDs) and third-party logistic providers (3PLs) to be licensed according to a national standard.
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In a May 27 Federal Register notice, the US Department of Health and Human Services (HHS) announced the reinstatement of the Unapproved Drugs Initiative, the FDA’s compliance policy governing marketed unapproved drugs. The announcement is an abrupt—but not unexpected—reversal from a previously issued controversial decision by the Trump administration’s HHS to end the Unapproved Drugs Initiative in November 2020. The reinstatement means that companies that market unapproved drugs should reassess their risk under FDA’s preexisting enforcement priorities.
In an apparent effort to combat prescription drug shortages and price spikes, the US Department of Health and Human Services (HHS) recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI). This announcement essentially walks back FDA’s enforcement approach regarding “marketed unapproved drugs,” allowing them to continue to be sold consistent with the 2006 FDA policy, and may cause objections from those companies that spent millions of dollars in scientific resources and application user fees to obtain New Drug Application (NDA) approval for these drugs over the last 14 years.
The Centers for Medicare and Medicaid Services (CMS) issued proposed regulations in February targeting manufacturer arrangements with pharmacy benefit managers (PBMs).
In FDA’s latest Director’s Corner podcast, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER or Center), reflects on the Center’s accomplishments of the past year and priorities for 2019.
After several delays, the revised US Federal Policy for the Protection of Human Subjects (also known as the Common Rule) went into effect on January 21.
FDA recently announced a proposal to add an exception to the agency’s informed consent requirements. Under the proposed rule, FDA will allow Institutional Review Boards (IRBs) to waive or alter informed consent for clinical trials that present only minimal risk to the subjects. This proposal is similar to the policy set forth in FDA’s guidance document on the same topic, which we have written on previously.