A lawsuit filed last year challenging a federal rule and certification allowing certain drugs to be imported from Canada should be dismissed because no drug companies have been harmed yet, nor are they likely to be any time soon, the Biden administration said in a motion seeking dismissal of the suit.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA blasts thermographic sensor system marketers; WHO to tackle breast cancer globally; PhRMA urges Biden to stand by IP rights; FDA ASCA workshop announced.
The Pharmaceutical Research and Manufacturers Association (PhRMA) filed suit Nov. 23 in U.S. district court challenging the Trump administration’s final rule allowing the import of prescription drugs from Canada.
The casual observer may think that physician speaker programs sponsored by makers of drugs and medical devices have drawn less attention from U.S. federal attorneys, but reality has failed to meet that expectation. Mark Gardner, managing attorney of Gardner Law of Stillwater, Minn., said on a Nov. 19 webinar that “there’s a lot coming through right now in terms of settlements,” including a settlement with a drug maker that sent the company into bankruptcy.
“Nothing to see here” seems to be the general reaction to the four executive orders President Donald Trump signed Friday in an effort to reduce U.S. prescription drug prices. Two of the orders – one on importing drugs from Canada and the other on kicking the safe harbor out from under the rebates pharmacy benefit managers (PBMs) get from drug companies – instruct Health and Human Services (HHS) to continue, or resume, rulemaking on those measures.
When it comes to guidance on interchangeables, the Pharmaceutical Research and Manufacturers of America (PhRMA) has some guidance for the FDA: Be more definite.
The Senate passed by a vote of 96-1 the spending bill for the outbreak of the new coronavirus (COVID-19), which will be on President Donald Trump’s desk by week’s end. The bill provides $7.8 billion in new funds to tackle the outbreak and another $490 million in existing funds for telehealth, all with the aim of speeding the response to the pathogen.
The U.S. FDA is well known for encouraging industry to meet with the agency “early and often” for complex premarket filings, but the Combination Products Coalition (CPC) says a recent draft guidance seems to offer the exception. The group said the December 2019 FDA guidance for feedback on combination product applications “seems to generally discourage” the use of the combination product agreement meeting (CPAM). It added that the complexity of some combination products suggests that such a meeting may well be crucial to an efficient application process.
