Hyman Phelps McNamara

By Kurt R. Karst – Now that the dust from 2015 has settled, we’re able to take a look at and evaluate the year that was in orphan drug designations and approvals. Our annual review has become quite popular.  We often see the numbers we provide …

In November 2013, the Drug Quality and Security Act (“DQSA”) was signed into law in an effort to increase the quality of the United States drug supply. The law contains two separate acts: the Compounding Quality Act (Title I), and the Drug Supply Chain Security …

By Kurt R. Karst –   The ink from President Obama’s signature on Public Law No. 114-89, the “Improving Regulatory Transparency for New Medical Therapies Act” (or “IRTNMTA”), was hardly dry when the company that led the charge to change the law, Eisai Inc. (“Eisai”), asked the …

By Allyson B. Mullen – On January 26, FDA issued the draft guidance “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” A copy of the draft guidance can be found here. The draft guidance addresses design and premarket issues related to the interoperability of devices, …

By Melisa M. Moonan – FDA has been flooding the zone with new guidance documents. Earlier this week, FDA finalized the human factors guidance, “Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff” (Feb. 3, 2016). At …

By John A. Gilbert, Jr. & Larry K. Houck – The Government Accountability Office (“GAO”) recently released a report examining issues related to state marijuana legislation and federal monitoring of such actions. GAO, State Marijuana Legalization: DOJ Should Document Its Approach to Monitoring the Effects of …

By Kurt R. Karst – Those folks who have been following this blog for several years have a good sense about the depths of this blogger’s passion for the Orange Book. There’s the license plate (“ORNGBUK”), the trip to the summit of Mt. Kilimanjaro with the …

By Allyson B. Mullen – On January 15, FDA issued the draft guidance “Postmarket Management of Cybersecurity in Medical Devices.”  This draft guidance is the postmarket counterpart to the draft premarket guidance that FDA released in 2013, which we previously posted on here and here.  Without finalizing the …

By Alan M. Kirschenbaum, Michelle L. Butler & David C. Gibbons – The February 1st Federal Register contains CMS’s final rule implementing changes to the Medicaid Drug Rebate Program (MDRP). The rule had been released for prepublication review on January 21. This rule, which has an effective date of …

By Allyson B. Mullen & Jeff N. Gibbs – Before the multiple feet of snow that the DC area recently received, CDRH had been creating its own storm of device guidance documents. One of the most recent ones is the final guidance “Submission and Review of …

By Melisa M. Moonan – FDA has granted stakeholders an additional 30 days to comment on its the December 31, 2015 draft guidance “Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').” The new deadline for comments is March 29, 2016.   We previously commented on …

By Kurt R. Karst – Whether in the context of asserting First Amendment protection for a pharmaceutical manufacturer’s off-label promotion of an otherwise approved drug (see our previous post here), or challenging FDA’s denial of New Chemical Entity (“NCE”) exclusivity for VASCEPA (icosapent ethyl) Capsules (NDA …

By Ricardo Carvajal –  It’s getting hard to turn around without bumping into a Food Safety Modernization Act (FSMA) consultant.  Perhaps it was inevitable, given the compliance dates that suddenly don’t seem so far away, the law’s many moving parts, and the mantra that FSMA is the most …

By Alan M. Kirschenbaum – Just ahead of a predicted snow storm in the Baltimore-Washington area, CMS yesterday issued a blizzard of 658 pages constituting its final regulation implementing changes to the Medicaid Drug Rebate Program. Although this is a final rule, CMS will be accepting comments …

By Ricardo Carvajal -  On January 4, FDA denied the Weston A. Price Foundation’s citizen petition seeking revocation of the health claim for soy protein and coronary heart disease (CHD).  As reported in a prior blog posting, the Foundation filed the citizen petition in 2008, and sued the …