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A Question of Intent: FDA Amends Intended Use Regulations with Goal to Provide More Clarity, but Significant Questions Remain

On August 2, 2021, FDA issued a final rule amending its drug and medical device regulations describing the types of evidence that FDA considers relevant to determining a product’s “intended use.” The concept of intended use is a cornerstone of FDA’s regulatory scheme that determines whether and how the Agency regulates a product as a drug or device. This final rule represents the culmination of a nearly six-years-long rulemaking process that generated extensive comments from stakeholders. Most significantly, the final rule clarifies that a firm will not be regarded as intending an unapproved new, or off-label, use for a drug or device based solely on that firm’s knowledge that the product was prescribed or used by health care providers for the use. More generally, FDA has made clear that it will continue to take a broad view of what evidence, including manufacturer communications and other information about the product, may be considered when determining intended use. The amended regulations also will expressly state for the first time that the “design or composition” of an article may be relevant to determining intended use.

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Video- Enforcement under a Jeff Sessions DOJ


Time to Read: 2 minutes Practices: Government Enforcement / White Collar Criminal Defense


Colleen Conry, Ropes & Gray government enforcement partner, provides insights on what to expect with enforcement activity under the Trump administration and a Jeff Sessions led Department of Justice.


Transcript:

A lot of clients are wondering what white-collar enforcement will look like in the Trump administration. I think some people assume President Trump will go easy on corporate crime—and there’s still a lot of uncertainty about his positions. But I think there’s good reason to expect that DOJ will continue to be very active in the corporate space.

Jeff Sessions is going to set the tone for the Department. He’s a tough, experienced prosecutor, and he’s taken a tough stance on white-collar crime. In the Senate, he’s talked about his record as U.S. Attorney in Alabama, and he reminds us that he sent bankers to jail during the Savings & Loan crisis. And he’s pushed for harsh sentences for individuals in white-collar cases, because he thinks they’re important to deter corporate misconduct.

Many of the key positions in the Department still need to be filled, but I think it’s telling that Sessions is looking to Rod Rosenstein as his Deputy Attorney General. Rod’s a career prosecutor. He’s well respected on both sides of the aisle. He’s been the Baltimore U.S. Attorney since 2005, which makes him the longest-serving U.S. Attorney in the Department. And before that, he was in the Tax Division at DOJ. To me, that all means he’s going to appreciate the complexity of the regulations businesses face and will want to give them a fair shake, but it also means he’s not afraid to bring a white-collar case.

It will be very interesting to see who’s appointed to U.S. Attorney positions in offices that historically generate a lot of white-collar cases. Preet Bharara has reportedly been asked to stay on in the Southern District of New York. Now, he’s an Obama appointee and has been very aggressive in prosecuting financial crime like insider trading. Of course many of the decisions in white-collar cases are made just above the line level. Those supervisor roles are usually held by career prosecutors. They don’t change the way they do their jobs with each election, so I don’t expect to see sudden changes in the way cases are handled.

I think we might see some shifting priorities at DOJ, but I think white-collar enforcement will stay strong. When you look back historically, even conservative administrations have been aggressive in white-collar cases—think about Enron and WorldCom under the Bush administration. And when you look at statutes like the False Claims Act, which accounts for a huge share of the Department’s corporate recoveries, you see the numbers increasing steadily across administrations.

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