Since as early as 2005, industry has asked FDA for its input on the listing of device patents in the Orange Book (see our previous post here). FDA has, for the most part, refused to address this question. As such, industry has decided to just …
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Prescription Drugs and Biologics
- If FDA Won’t Regulate, Maybe the Courts Will: First Circuit Opines on Listing Device Patents in the Orange BookMarch 16th, 2020
- Court Determines that Decade’s Worth of Missing Data Must Be Published on ClinicalTrials.gov but Enforcement of Reporting Violations Hinges on FDA DiscretionMarch 9th, 2020
Judge Naomi Buchwald of the District Court for the Southern District of New York recently found that the Department of Health & Human Services (“HHS”) misinterpreted a federal law requiring it to collect and post data for certain clinical trials, resulting in a 10-year gap …
- HP&M’s Own Prevails in a Battle of the ExpertsMarch 6th, 2020
In a recent decision out of the Seventh Circuit, Antrim Pharms. Llc. v. Bio-Pharm, Inc., 2020 U.S. App. LEXIS 4772* (7th Cir. 2020), the court decided a battle of the experts: Bio-Pharm prevailed after Antrim unsuccessfully argued the court should preclude testimony by Bio-Pharm’s expert, HP&M’s …
- Vanda Isn’t Dropping This Bone Despite Negative Court DecisionFebruary 21st, 2020
Blog readers may be thinking, “HPM, didn’t you just blog about the Vanda case last week?” We certainly did (and had previously here and here). You will recall that Vanda Pharmaceuticals did not prevail in its quest to have the Court find that FDA’s imposition …
- Paw Shucks: Court Defers to FDA’s Request for Additional Animal StudiesFebruary 18th, 2020
Animals, shmanimals. Or so says FDA. Well, FDA didn’t actually say that, but that’s the effect of the District Court of D.C.’s recent ruling in Vanda Pharmaceuticals v. FDA. In a case we have been following for the last year or so, the District Court …
- Does Your Unapproved Device, Drug or Biologic Qualify for an Emergency Use Authorization (EUA)?February 14th, 2020
The FDA is taking very seriously the threat of the coronavirus from China (2019‑nCoV). Makers of medical devices, drugs and biologics should consider whether their products can contribute to countering this threat. In late January, FDA announced its strategy to advance development of medical countermeasures to …
- Acetris Case – Federal Circuit Rules that a Drug Tableted in the U.S. is Manufactured in the U.S. and Eligible for Government ProcurementFebruary 14th, 2020
On February 10, the Court of Appeals for the Federal Circuit ruled that the Department of Veterans Affairs (“VA”) erred in interpreting the Trade Agreements Act of 1979 (“TAA”) and the Federal Acquisition Regulation (“FAR”) to exclude from procurement pharmaceutical products that are manufactured in …
- Knives Out: Carving Up an aBLAFebruary 12th, 2020
As more biosimilars are approved (we’re up to 26 now!), FDA has been rolling out guidance documents under the Biosimilars Action Plan (“BAP”). The most recent guidance has been long awaited. While the Hatch-Waxman Act explicitly provides that an applicant can seek approval for only …
- The Value of Priority Review Vouchers – GAO’s Two CentsFebruary 11th, 2020
Congress enacted several priority review voucher (“PRV”) programs in the past fifteen or so years with the goal of incentivizing drug companies to develop new drugs for diseases that ordinarily may not be attractive because the potential market is small or otherwise unlikely to produce …
- FDA Law Alert – February 2020February 10th, 2020
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 …
- Dueling It Out with FDA over NCE ExclusivityFebruary 7th, 2020
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 …
- FDA and FTC Announce New Steps Under the Biosimilars Action Plan, Which Include Targeting False and Misleading Statements About BiosimilarsFebruary 5th, 2020
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 …
- FDA’s Getting Its Priorities Straight: Revised ANDA Priority MAPPFebruary 3rd, 2020
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 …
- ACI’s 35th FDA Boot Camp – New York EditionJanuary 31st, 2020
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 …
- California Dreaming Part 2: The Constitutional ChallengeJanuary 29th, 2020
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 …