In a blog entry written over the summer, I expressed the view that the next 5-10 years will present tremendous transactional opportunities in the life sciences/health care industry. Nothing has happened to dampen that view. In fact, President Obama’s reelection, which means that the Patient Protection and Affordable Care Act is here to stay and will be fully implemented over the next few years, and our ongoing deficit reduction concerns, mandate that efficiency, cost control and strategic ways to provide better quality healthcare will be at center stage. So let’s focus in on some investment opportunities that may be interesting.

For those willing to tackle regulatory and reimbursement hurdles, there should be many opportunities in the provider world. This could take the form of hospital mergers and consolidations, spin-off of various medical and lab services that have been provided at hospitals and … Read More »

Last week’s decision in the off-label promotion case, United States v. Caronia, No. 09-5006-cr (2d Cir. Dec. 3, 2012), is an important blow to the Government’s off-label promotion efforts.  In a 2–1 decision, the Court squarely rejected the simplistic theory that the Food, Drug and Cosmetic Act (“FDCA”) imposes a blanket prohibition against off-label promotion by pharmaceutical and device manufacturers, but it does leave open the door to future prosecutions that rely in part on off-label promotion.

In Caronia, the Department of Justice obtained the conviction of Alfred Caronia, a pharmaceutical sales representative, for conspiracy to introduce a misbranded drug into interstate commerce.  The FDA prohibits the introduction into interstate commerce of a misbranded drug (or device).  31 U.S.C. § 331(a).  A drug is misbranded if, among other ways, its labeling fails to contain “adequate directions for use,” 21 U.S.C. § 352(f), … Read More »

The relationship between health care providers and drug and device manufacturers has been a focus of lawmakers at both the federal and state level.  While we continue to await final federal regulations implementing the Physician Payment Sunshine Act (federal Sunshine Act), which generally requires disclosure of financial arrangements among physicians, teaching hospitals, and drug and device manufacturers,[1] Massachusetts has refined its requirements governing relationships between physicians and drug and device manufacturers.  Amendments to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct regulations[2] (the Massachusetts Regulations) broaden the scope of permissible meals and refreshments that may be provided by manufacturers to health care practitioners and clarify issues related to preemption of the Massachusetts Regulations by the federal Sunshine Act.  The Massachusetts changes and impending release of final federal regulations underscore the continuing need for drug and device manufacturers to … Read More »