Hyman, Phelps & McNamara's attorneys counsel and assist HPM clients in gaining government approvals for new products and in developing strategies to support successful marketing in accordance with the requirements of the law and the enforcement policies of FDA and other regulatory agencies.
By Delia A. Deschaine & Larry K. Houck – In just shy of three months following receipt of the Department of Health and Human Services (“HHS”)’s rescheduling recommendation, see prior post here, DEA announced the issuance of a Notice of Proposed Rulemaking (“NPRM”) Thursday to reschedule all hydrocodone combination products (“HCPs”) from schedule III to schedule […]
By John R. Fleder – In litigation brought by or against FDA, the agency frequently seeks to avoid a “jump-ball” by arguing that FDA’s position is entitled to deference by the court. That argument is consistently made in civil cases and has been made in some criminal cases. A Supreme Court ruling on February 26, […]
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
By JP Ellison – On February 25th, the Solicitor General’s Office weighed in on whether the Supreme Court should take up a case involving False Claims Act allegations arising out of alleged off-label promotion of a drug. The case is Nathan v. Takeda, and the United States Court of Appeals for the Fourth Circuit ruled […]
By Kurt R. Karst – It’s “Exclusivity Week”! First there was FDA’s Draft Guidance that, if finalized, would reinterpret the 5-year New Chemical Entity (“NCE”) exclusivity provisions of the FDC Act to award NCE exclusivity to a newly approved Fixed-Dose Combination (“FDC”) drug containing an NCE and a previously approved drug. That announcement was […]
By Riëtte van Laack – The Over-the-Counter (“OTC”) drug regulatory framework was established by FDA more than 40 years ago in the OTC Drug Review. The procedure was intended to lead to a monograph which described the active ingredients and conditions that are generally recognized as safe and effective (“GRASE”) for each of more than […]
By Kurt R. Karst – Even before FDA gave up an appeal of Judge Edward R. Korman’s April 2013 Judgment and Order that Teva Branded Pharmaceutical Products R&D, Inc.’s (“Teva’s”) PLAN B One-Step (levonorgestrel) Tablets, 1.5 mg (“PBOS”), be made available Over-the-Counter (“OTC”) without age or point-of-sale restrictions (see our previous post here), we were […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
By Kurt R. Karst – In moves that may displease both brand-name and generic drug manufacturers, and that could lead to litigation from both sides, FDA has with one hand proposed to giveth New Chemical Entity (“NCE”) exclusivity to certain Fixed-Dose Combination Drugs (“FDCs”) and has with the other hand taketh away the possibility of […]
By Jeffrey N. Wasserstein – Either Sen. Lamar Alexander (R-Tenn) reads the FDA Law Blog, or great minds truly think alike. On Feb. 20, 2014, Sen. Alexander wrote to Secretary of Health and Human Services (HHS) Kathleen Sebelius asking her to clarify HHS’s position regarding patient access to health information, noting the same discrepancy between […]
By James C. Shehan – Vermont law has banned manufacturers of prescription drug, device, and biologics products from providing most gifts to physicians and other healthcare professionals since 2009 and has required these manufacturers to report permitted gifts and payments to Vermont HCPs since 2002 (summarized in our previous post here). On February 4, 2014, […]
By Allyson B. Mullen – On February 14, 2014, FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit MDRs in an electronic format (the “Final Rule”). 79 Fed. Reg. 8832 (Feb. 14, 2014). The Final Rule does not materially change the underlying requirements […]
Gabby Everett, the site director for BioLabs Pegasus Park, offered a tour of the space and shared some examples of why early-stage life science companies should choose North Texas.
By Kurt R. Karst – Last Friday, BioMarin Pharmaceutical Inc. (“BioMarin”) and FDA announced (here and here) the approval of a BLA for a new biological product for patients with Mucopolysaccharidosis type IVA, also known a “Morquio A syndrome”: VIMIZEN (elosulfase alfa) Injection. The approval of VIMIZEN not only marks the first FDA-approved product for Morquio […]
By Ricardo Carvajal – FDA published a notice announcing the availability of a Draft Approach for Designating High-Risk Foods, and asking for comments and information to help the agency refine that approach. Designation of a food as a High-Risk Food (HRF) would trigger additional recordkeeping requirements intended to facilitate product tracing (current recordkeeping requirements for purposes […]
By Jennifer D. Newberger – On February 5, 2014, the Center for Devices and Radiological Health released its 2014-2015 Strategic Priorities, in which it stated that the most important areas of focus over the next two years will be to “strengthen the clinical trials enterprise,” “strike the right balance between premarket and postmarket data collection,” […]
By Kurt R. Karst – The Electronic Age has changed nearly every aspect of our daily lives, and the day-to-day operations of the U.S. Federal Government are no different. The government is no longer open for business from 9-5, but rather 24 hours a day by virture of electronic media. This 24-hour business day cycle […]
By Jennifer D. Newberger & Alan M. Kirschenbaum – Last Friday, CMS issued a notice announcing the opening of registration for electronic Open Payments reporting under the physician payment sunshine provisions of the Affordable Care Act. (A previous post on the sunshine provisions and our memo summarizing CMS’s final implementing rule can be found here.) […]