Our highly experienced team guides life sciences clients through every aspect of the complex and evolving FDA regulatory landscape. With extensive understanding of the development and life cycle management of pharmaceutical products and medical devices, our lawyers–including former general counsel for Novo Nordisk, Forest Laboratories, and Robert Wood Johnson University Hospital Rahway, and in-house counsel for Savient Pharmaceuticals, Reliant Pharmaceuticals, Pfizer, and the FDA–understand the risks and rewards facing our clients in this sector.
The team works closely with our extensive, multidisciplinary Life Sciences Practice Group to advise and represent companies of all sizes, from startups to global leaders. We provide guidance on FDA regulatory issues related to product development and commercialization, post-approval promotion and compliance, intellectual property, government enforcement actions, and mergers and acquisitions.
We also are frequently tapped to share our perspective on the regulatory challenges shaping the global health care industry, and to speak at industry conferences, congressional briefings, and FDA public hearings. Companies turn to us for practical counsel in regard to related government agencies, including the Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA), and the Consumer Product Safety Commission (CPSC).
James C. Shehan is quoted in the Pink Sheet regarding Sarepta Therapeutics Inc.’s decision to not publicly disclose its submission of a formal dispute resolution request appealing the FDA’s rejection of the drug Vyondys 53. Shehan notes that the legal standard for determining whether information such as this must be disclosed is how material is it to an investor’s buy or sell decision and that, because companies don't often win formal dispute resolutions with the FDA, Sarepta’s decision to not disclose the appeal’s existence could be legally permissible. (subscription required to access article)
James C. Shehan is quoted in The Center for Biosimilars in an article discussing the nomination of Stephen Hahn to be the next FDA commissioner and whether his selection would mean continued advancement for biosimilars, as was the case during Scott Gottlieb and Ned Sharpless’s tenures. Shehan notes a major shift in the U.S. market’s need for biosimilars, with Gottlieb’s time as commissioner representing a “quantum leap in terms of activism.”
James C. Shehan, Chair of Lowenstein’s FDA Regulatory practice, comments in Law360on the D.C. federal court ruling that struck down the Trump administration rule requiring drug prices to be disclosed in TV ads. U.S. District Judge Amit P. Mehta found that there was no basis in either statute or legislative history to support the authority of Department of Health and Human Services (DHHS) to make such a rule. Shehan notes the judge’s “powerful argument” that if DHHS’s general powers were extended to include the authority to force price disclosure in commercials, “it could also use that authority” to regulate many other subjects not identified in the law, “like medical school tuition rates or hospital executive compensation.” (subscription required to access article)
James C. Shehan, Chair of Lowenstein’s FDA Regulatory practice, is interviewed on the “Not So Different” podcast by the Center for Biosimilars on the FDA’s recently released final guidelines on demonstrating interchangeability, which Shehan knows well because he helped craft the sections of the Biologics Price Competition and Innovation Act that govern interchangeability. He also addresses the upcoming transition of insulin to its regulation as a biologic instead of as a drug, and the possibility of it being categorized as an interchangeable one day.
A video interview with James C. Shehan, Chair of Lowenstein’s FDA Regulatory practice, on the FDA’s new approach to citizen petitions aimed at delaying market entry of products, was published on the CenterForBiosimilars.com. Shehan explains that the agency has issued more details on the criteria it will use in deciding whether a petition’s primary purpose is to delay generic competition.
James C. Shehanis quoted in CenterForBiosimilars.com, BioPharma Dive, and Modern Healthcarediscussing what the biosimilars industry will look like once FDA Commissioner Scott Gottlieb, MD steps down this April. Shehan notes that Gottlieb represented “a quantum leap in terms of activism” and “has gotten far and away the highest job marks of any commissioner we’ve seen, particularly when you consider that he has gotten respect across the board, which is unusual”, further noting the change in approach to the biosimilars market Gottlieb has taken during his tenure at the FDA resulting in a more competitive drug market. Shehan observes that Gottlieb’s legacy will encourage his successors to “be more communicative with the public and more willing to take a role in some of the great public health controversies”, he further provides that the industry’s concern is rooted in the uncertainty of who the next commissioner will be and if he or she will be able to keep this positive action going.
James C. Shehan is quoted in an article discussing high drug prices and Congressional activity aimed at driving down rising costs. In The American Journal of Managed Care, his interview with The Center for Biosimilars is referenced, with Shehan commenting that the U.S. Congress has been “all talk and no action” for the last decade. States, however, Shehan notes, have taken concrete action on drug pricing, with almost every state having considered some kind of proposal and a number of laws enacted.
James C. Shehan is quoted in Law360 in an article discussing the Administration’s proposed regulation forcing disclosure of drug prices in TV ads. Shehan notes that the proposal pushes the limits of existing legal authority.
Pink Sheet quotes James C. Shehan in an article reporting pharmaceutical company Sanofi’s settlement with the U.S. Securities and Exchange Commission for violating the Foreign Corrupt Practices Act (FCPA). The article notes that this settlement follows a relatively quiet period for FCPA settlements. Shehan attributes the lack of FCPA enforcement activity to the fact that “there are fewer easy cases out there for prosecutors to go after,” that there can be a long period between the alleged violation and resolution of the case, and that companies have generally become more compliant with the law. (subscription required to access article)
Law360 interviews with James C. Shehan on a broad range of issues, including: critical skills for being a successful FDA lawyer, a move to streamline the FDA’s approval process, patent litigation involving biosimilars, FDA updates to off-label promotion guidance, a push in favor or competition and generics, and understanding why the FDA has reduced the number of warning and untitled letters for promotional issues. (subscription required to access article)
Law360 quotes James C. Shehan in an article discussing the likelihood of an increase in litigation against U.S. Food & Drug Administration (FDA) policies should the Hon. Brett Kavanaugh of the U.S. Court of the Appeals for the District of Columbia Circuit be confirmed to the U.S. Supreme Court. Judge Kavanaugh has criticized the Supreme Court’s Chevron doctrine, which mandates judicial deference to reasonable administrative agency interpretations of ambiguous federal laws, as enabling agencies to “stretch the meaning of statutes.” Shehan predicts that a shift by the Court on Chevron will spark more lawsuits against the FDA. He notes that while Chevron may still inspire judicial deference in cases involving complex scientific matters, any lessening of deference more generally would diminish the FDA’s authority. (subscription required to access article)
Modern Healthcare quotes James C. Shehanin an article profiling U.S. Food and Drug Administration commissioner Dr. Scott Gottlieb’s positive performance to date. Shehan states that Gottlieb is “the most prominent FDA commissioner in terms of getting out in front of the public” and that he is garnering approval from both the public and the pharmaceutical industry.
Modern Healthcare quotes James C. Shehan, Head of Lowenstein’s FDA Regulatory Practice, on how the FDA’s new Medical Device Safety Action Plan will fill gaps in device regulation and may portend further FDA action in other areas.
James C. Shehan, Head of Lowenstein’s FDA Regulatory Practice, is quoted in Modern Healthcare regarding the security of medical devices pertaining to health systems, noting the lack of absolute security in the electronic world.