Yesterday’s FDA Warning Letter, Press Release, and accompanying public relations campaign related to AcelRx’s promotional material for Dsuvia (sufentanil) are remarkable for exactly the reasons FDA intended them to be remarkable: these actions all signal to industry that despite anemic levels of FDA enforcement related …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 36th iteration – is scheduled to take place from March 24-25, 2021 (Eastern Time). The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult …
In late November, the OIG published a final rule that excludes from the Federal healthcare program safe harbor for discounts rebates paid to Medicare Part D plans, or their PBMs (see our post here). The rule also establishes two new safe harbors: one for rebates …
In the waning days of the Trump administration, the Department of Health and Human Services announced a fairly significant change in addiction medicine policy. The new policy permits physicians (and only physicians) more flexibility to prescribe buprenorphine – a much used and effective drug that …
2020 was unprecedented and tumultuous due to simultaneous challenges of a once-in-a-century global pandemic, the resulting socio-economic fallout, and political polarization regarding policy responses to the pandemic, civil rights protests and presidential elections. The FDA has been pressured and challenged and responded with varying degrees of …
As we previously reported (see here and here), in three separate cases, federal courts blocked the implementation of the Most Favored Nation (MFN) rule for Medicare Part B drug payment. (Our summary of the MFN rule is available here.) In December 2020, the District Court …
Those of you keeping up with the Orange Book know that FDA has been considering changes to patent listing requirements, many of which industry has been requesting for decades. Now, Congress is trying to facilitate effective administration of the Orange Book. On January 5, 2021, …
On December 30, 2020, District Court Judge Kenneth M. Karas of the Southern District of New York issued a nationwide preliminary injunction preventing the Most Favored Nation (MFN) rule from applying to Regeneron’s drug EYLEA (aflibercept). This is the third federal court ruling preventing implementation …
In the New Year’s Eve edition of the Federal Register, CMS published a final rule to implement statutory amendments to the Medicaid Rebate Program statute, and to add CMS’s own policy proposals to encourage value based purchasing arrangements and discourage patient copay assistance. The variety of …
Two district courts recently dealt what may become fatal blows to the Trump administration’s Most Favored Nation (MFN) rule for Medicare Part B drug payment. As noted in our summary (available here), the MFN rule was published as an interim final rule with comment period …
Buried in the 2,124-page Consolidated Appropriations Act, 2021 (the Act), which was signed by Donald Trump yesterday, was a brief provision requiring the reporting of average sales price (ASP) by manufacturers that do not have a Medicaid Drug Rebate Agreement. ASP is used by CMS …
Biosimilars have been around for a bit over 10 years now, and there has been tremendous progress in licensing new biosimilar products. But there is no question that there are still significant holes that FDA must address to further facilitate biosimilar development under section 351(k) …
In October, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) published a Final Rule that permits the importation of prescription drug products from Canada (the “Final Rule”). The Final Rule became effective on November 30, but the potential …
On December 4, 2020, FDA finalized the guidance document, Requesting FDA Feedback on Combination Products (Guidance), which was issued to fulfill the requirement under Section 3038 of the Cures Act. As a reminder, Section 3038 contained several provisions to help facilitate FDA engagement and appropriate …
For over nine months FDA has dithered on whether and, if so how, to conduct remote inspections of drug facilities during the pandemic. On the other hand, many foreign regulatory bodies appear to have implemented just such a system of remote inspections. Has FDA just …
