Hyman, Phelps & McNamara, P.C. is pleased to publish the first FDA Law Alert of the new year. This is the fourth installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to …
Those familiar with the Hatch-Waxman Act and its various incentives to stimulate drug innovation know that New Chemical Entity (“NCE”) exclusivity is the holy grail of small molecule exclusivity. Though orphan drug may give a sponsor two more years of exclusivity than NCE, it only …
On February 3rd, FDA announced several new actions as part of its Biosimilars Action Plan (BAP). If you recall, back in July 2018 when FDA first unveiled the BAP, four key elements were identified: improving efficiency of biosimilar and interchangeable product development; maximizing scientific and …
Only about 2 years after its last revision (which was only 5 months after its previous revision), FDA decided this week that MAPP 5240.3, Prioritization of Original ANDAs, Amendments, and Supplements, just wasn’t working. With too many ANDA submissions designated as priority, and thereby entitled …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 35th iteration – is scheduled to take place from March 24- 25, 2020 at DoubleTree By Hilton Metropolitan, New York, NY. The conference is billed as the premier event to provide folks with …
Back in September 2019, California passed AB 824: Preserving Access to Affordable Drugs. That law sought to discourage “reverse-payment agreements” in which a brand manufacturer enters into a patent settlement agreement with a potential generic sponsor that involves a transfer of value from the brand …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Serra Schlanger will present at this year’s Drug Pricing Transparency Congress, to be held in Philadelphia, PA on March 30-31, 2020. This conference gathers stakeholders to examine the evolving landscape of state drug price reporting …
Too often, children are not included in clinical trials for new drugs, even though children may eventually be prescribed those very same drugs. This forces physicians who treat children to try and extrapolate information collected from adult trials to determine if and how to use …
On December 9, 2019, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a civil action in the United States District Court for the District of Oregon seeking declaratory and injunctive relief against the Acting Director of the Oregon Department of Consumer and Business Services …
On December 18, 2019, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a Notice of Proposed Rulemaking (NPRM) and a Draft Guidance for the importation of certain prescription drugs. The NPRM and Draft Guidance provide further details …
On December 13, 2019, Nature Reviews Drug Discovery published an article that reviews the landscape of the development of drugs for rare diseases, both the progress and challenges. The article was authored by HP&M Attorney James E. Valentine along with co-authors from the BioPontis Alliance …
Subcommittees of the House Committee on Energy and Commerce heard testimony last week from the Government Accountability Office’s Mary Denigan-Macauley and from Janet Woodcock, Director of FDA’s Center of Drug Evaluation and Research, about the state of FDA’s foreign drug establishment inspection program. FDA generally conducts …
Earlier this week, House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR) and Senate Health Committee Chairman Lamar Alexander (R-TN) announced that they reached agreement on a bipartisan, bicameral drug pricing bill, called The Lower Health Care Costs Act …
The distinction between a drug and a device is a critical one: drugs and devices are subject to different regulatory schemes, with the drug pathway being significantly more onerous and expensive. User fees alone for a generic drug total $300,000 for the first year compared …
As we move in to 2020, FDA is fastidiously preparing for the event 10 years in the making: the transition. For those of you unfamiliar with the “transition,” it refers to the “deemed to be a license” provision of the Biologics Price Competition and Innovation …
