Legislative Overseers Continue to Criticize FDA for its Regulation by Guidance


Four members of the Senate Health, Education, Labor, and Pensions Committee (HELP), including Chairman Lamar Alexander, wrote Food & Drug Administration (FDA) Commissioner Robert Califf earlier this month to reiterate their concerns with FDA’s use of guidance as regulatory tool. Members of the committee had previously written the FDA Commissioner about the agency’s use of guidance in May 2014, to which FDA responded nearly a year later in March 2015. During his confirmation hearing before the HELP Committee last November, Commissioner Califf addressed several questions about the use of guidance and pledged to investigate the Senators’ questions. Continue reading

WLF Media Briefing, New Paper Address the Freeing of Off-Label Medical-Product-Use Information

On Monday, May 2, 2016, Washington Legal Foundation hosted a program in its Media Briefing series entitled Freeing Off-Label Use Information: Three Lingering Questions for Medical-Product Innovators and Regulators. The recording of that program is available below. Also below are links to related materials, including an April 29, 2016 WLF Legal Backgrounder that draws lessons from a medical-device company’s successful defense of a criminal prosecution for alleged off-label promotion.


  • Edward Berg, Sanofi US
  • John Osborn, Hogan Lovells LLP
  • Coleen Klasmeier, Sidley Austin LLP
  • Eric Grannon, White & Case LLP (moderator)

The program can also be viewed through WLF’s website—with a higher-quality video and integrated slides—by clicking here.

John Osborn’s Yale Journal article, “Can I Tell You the Truth?”, cited by the U.S. Court of Appeals for the Second Circuit in U.S. v. Caronia, is available here.

WLF’s Legal Backgrounder, “The US v. Vascular Solutions Acquittal: Three Lessons for Targets of ‘Off-Label Promotion’ Enforcement,” is available here.

High Court’s Cert Denial Should Put an End to Novel Anti-Preemption Claim in Medical-Device Suits

ReedGuest Commentary

by Matthew A. Reed, Sedgwick LLP

When plaintiffs bring state tort causes of action against the manufacturers of medical devices that have passed the Food and Drug Administration’s (“FDA”) rigorous pre-market approval (“PMA”) process, they enter a realm highly regulated by the federal government, and thus face a daunting task to avoid dismissal of their claims. They must demonstrate that their state-law claims require nothing more or different of the manufacturer than what the federal Food, Drug, and Cosmetic Act (“FDCA”) already requires, or else their claims are not “parallel” and thus expressly preempted by § 360k of the Medical Device Amendments (“MDA”) to the FDCA. But they also must show that their claims are based on state law distinct from the FDCA, because claims predicated on the FDCA are impliedly preempted as private attempts to enforce federal law. Continue reading

Supreme Court’s First 2016 Conference Yields Positive Results for Free-Enterprise Advocates—and Reason to Hope for More

supreme courtThe U.S. Supreme Court held its first Conference of 2016 on Friday, January 8, where it considered cert petitions in several high-profile cases impacting free enterprise. The Court issued an orders list on January 11 from that Conference, which, while it did not include any cert grants in these cases, potentially offers positive results for free-market enthusiasts.

First, the Court issued a CVSG in State Farm v. U.S. ex. rel. Rigsby. For those not versed in Supreme Court-speak, CVSG=Calling for the Views of the Solicitor General. The U.S. government is not a party in Rigsby, but because the case involves a key federal law, the False Claims Act (FCA), the justices want to give the government a chance to weigh in with a yay or nay on cert before deciding. It takes the vote of four justices—the same number it takes to grant cert—for the Court to seek the Solicitor General’s views. A CVSG is thus a very good sign that the Court has an elevated interest in a case. Continue reading

The Supreme Court’s NOT Top 10: October 2013 Term Cases the Justices Wrongly Passed Over

supreme courtThe Supreme Court press and other court observers have spilled a lot of ink this past month discussing the cases the Supreme Court took and decided during October Term 2013. Relatively little was said about the cases the court chose not to decide—and it passed over some doozies. But as Rush drummer and lyricist Neil Peart put it so eloquently, “If you choose not to decide, you still have made a choice.”

Pro-Business? Journalists like to portray the Roberts Court as particularly business friendly (see, e.g., here , here, and here; but see here), but businesses asked the Court to take plenty of cases this past term that it instead declined. When the Court denies cert in cases of such importance to business at the same time that it has a historically light docket, it can hardly be said to be pro-business. Companies crave legal certainty, so even if the Court took these cases and decided them against business interests, many times simply settling contested questions would be better than leaving them up in the air.

Wanted: More Business Cases. The Court needs to hear more business cases than it currently is, for at least two reasons. First, the unprecedented proliferation of new regulations by this administration has given rise to many more conflicts of the kind that produce Supreme Court cases. Second, to the extent the Clinton-and-Obama-appointee-dominated lower courts are predisposed against business litigants (or, more charitably, deciding close questions consistently against them), businesses will appeal more cases to the Supreme Court when they believe a lower court has denied them justice. Of course the Supreme Court justices take neither of these criteria into consideration when assessing individual cases, but surely these factors matter when assessing whether the Court leans in favor of business in forming its docket. Continue reading

Pharmaceutical Association’s Blog Features WLF Guest Post on U.S. v. Caronia, One Year Later Program

The blog of the Pharmaceutical Research and Manufacturers of America (PhRMA), The Catalyst, published a guest post from Washington Legal Foundation on Friday, January 31, Greater Clarity Needed Regarding What Scientific Information Biopharmaceutical Companies Can Communicate to Healthcare Providers.

The post, which features a foreword by PhRMA General Counsel Mit Spears, recounts the content of a January 16 WLF Media Briefing, U.S. v. Caronia, One Year Later: The First Amendment And Federal Oversight Of Off-Label Drug And Device.

The briefing can be viewed in its entirety by clicking on the title above.

Welcome to “Sorrellonia”!: WLF Seminar Assesses Off-Label Drug Speech Ruling

PodiumPic1Off-Label Speech After U.S. v. Caronia: Implications for Drug & Device Regulation and the First Amendment, a Washington Legal Foundation Web Seminar program, is now available for on-demand viewing.

Our program featured analysis and commentary from Coleen Klasmeier of the Sidley Austin law firm and WLF’s Chief Counsel, Richard Samp. Coleen and Rich make reference to a Powerpoint slide deck, which due to a technical problem wasn’t available to viewers during the program.  The slide deck can be downloaded here.

For her presentation, Coleen coined the term “Sorrellonia” because the U.S. Court of Appeals for the Second Circuit two-judge majority in Caronia became the first court to fully apply the holding and rationale of the U.S. Supreme Court’s 2011 Sorrell v. IMS Health opinion.

Coleen’s and Rich’s presentations drew upon their combined years of experience in dealing with FDA’s application of its off-label speech restrictions and the Justice Department’s prosecution of cases where criminal violations of those rules allegedly occurred.

While they both saw great promise in the opinion for greater freedom in the exchange of critical medical information, they also offered firm notes of caution that the ruling not be interpreted as a green light for businesses’ promotion of off-label uses. Great peril still exists in this area they warned, a fact that is all the more apparent today with the announcement of another nearly $1 billion Justice Department settlement with a pharmaceutical company.