On March 11, 2025, the EU formally proposed a regulation to not only fight drug shortages but also to maintain its status as a global leader in the production of pharmaceutical products. We have previously published a blog that identified the convergence of U.S. and EU efforts that can be found here. While the U.S. navigates […]
How is your company reacting to threats in its supply chain and transforming risk into opportunity? In a mature application of Quality Risk Management (QRM), companies should lean into the political winds of “onshoring,” “nearshoring,” and “friendshoring” as these concepts have been stood up as well-discussed risk mitigations to the current drug shortage problems. These […]
While I can’t remember how many of these meetings I have attended over my 40 years, so far this rates with the best of them for a couple of reasons. AAM’s new President and CEO, John A. Murphy III, and we got to meet him for the first time. We profiled John in a previous […]
Did you ever REALLY wonder what is being done by our federal government and other stakeholders to combat the current drug shortage situation? This past June 12th, representatives from various government agencies as well as industry leaders and the Duke-Margolis ReVAMP Drug Supply Chain Consortium (with yours truly participating on the expert panel) met to […]
The current FDA Drug Shortage List (here) identifies 110 drugs in shortage. Please note that the list contains 128 entries, but 18 of the drugs on the list are reported with their shortage status as resolved. In contrast, the American Society of Health-System Pharmacists (ASHP) lists 254 products on its drug shortage list (here). Apparently, […]
During her session yesterday at the AAM Annual Meeting, Iilun Murphy, M.D. provided additional details on the 2023 OGD metrics, indicating that there were 950 ANDAs approved and tentatively approved (782 and 172 approvals, respectively). Of the approvals, there were 90 first generics, along with 83 generics with Competitive Generic Therapy Designation, and 111 complex […]
Back in August 2023, we reported the approval of a significant number of Lisdexamfetamine ANDAs (here) that we believed would mitigate the ongoing shortage. Today, however, the FDA reported (here) that Lisdexamfetamine capsule dosage-form products are in trouble again. On the list of Lisdexamfetamine Dimesylate Capsule drug shortages are eleven companies, with only two of […]
Did you ever want to do something to help half a million consumers (on average) who are impacted by a drug shortages? This may seem daunting and based on the last few years almost impossible, but the first step is clear: increase your or your company’s awareness of the situation. Knowledge is power. Lachman is […]
Today, the Association for Accessible Medicines released a White Paper (here) that provides their views of the factors that may cause drug shortages and also provides some reasoned solutions to reduce and help prevent future drug shortages. While the white paper does indicate that the number of shortages has decreased somewhat over the past few […]
In a complete supply chain, one site’s lag measure is another site’s lead measure. As important as data integrity is to product quality decisions at the site, data risks in the supply chain can affect availability of product to patients. As mentioned in a previous Lachman blog (here), drug shortages are the preeminent risk for […]
