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…only compensatory damages. The questions NPS presents in the case are: 1. Whether the FDA’s exclusive authority to punish violations of federal law governing the lawful marketing of prescription drugs…
OPDP is coming out! On the heels of a nuanced and more complicated Warning Letter addressing CFL claims and statistical presentations comes a new Untitled Letter from OPDP going back…
…antitrust enforcers have a keen interest in ensuring that generic exclusion results from the strength of the patent rather than rivals’ common interest in eliminating competition and sharing the spoils…
…January 1, 2015 in any transactions involving a prescription drug product. The DSCSA also mandates that FDA issue a draft guidance document by November 27, 2014 that establishes standards for…
…Federal Food, Drug, and Cosmetic Act. The amendment addresses confusion over a compounding pharmacy’s “distribution” of compounded preparations and, specifically, compounding for office use (i.e., compounding preparations that are not…
…avoid possible disruptions in the prescription drug supply chain as the new requirements come into effect. For more recent news on the DSCSA, see our prior posts here, here, and here. …
…a number of companies in lawsuits brought by the Department of Justice. However, in addition to the Justice Department’s right to commence litigation under FCA, individuals who are often referred…
…to be included in television advertisements for certain prescription drugs and biological products (the “Price Disclosure Rule”) (see our overview of the Rule here). Judge Mehta’s decisioncame the day before…
…prescribers with the names of at least three generic prescription drugs from the same therapeutic class. Although the state has not yet issued regulations or guidance regarding these “Prescription Drug…
…application. Similar to the complaints PhRMA filed challenging similar laws in California and Nevada (see our coverage here, here, and here), PhRMA’s latest complaint alleges that HB 4005 and HB…
…written comments and in-person presentations. And, unlike FTC’s November 2017 workshop on competition in prescription drug markets where FDA was a presenter, the upcoming biologics competition workshop is clearly an…
…We know that, in the context of payor communications, the Office of Prescription Drug Promotion (and before it, the Division of Drug Marketing, Advertising and Communications – DDMAC) has long…
As we move into the heat of the summer, we can look forward to the annual June deluge of opinions coming from the Supreme Court. Last week, the Court ruled…
…Interstate Commerce with Intent to Defraud and Mislead. No Prescriptions Counts 95 and 99-100 charged Mr. Cadden with dispensing drugs into interstate commerce without valid prescriptions. The government needed to…
…prescription drug approval process, and more importantly the “exportation” of prescription pharmaceuticals — including controlled substances — from Puerto Rico into the United States. Some of the other (but not…