The Food and Drug Administration (FDA) faces a difficult balancing act in its role as the federal regulator of drug and medical-device manufacturers. On the one hand, it is charged with ensuring that medical products are both safe and effective for their intended uses. On the other hand, it must avoid imposing overly stringent regulations, lest it harm public health by blocking or delaying access to life-saving products, or to truthful information about those products.
Through its public-interest litigating, publishing, and communications capabilities, Washington Legal Foundation has long been at the forefront of efforts to ensure that FDA maintains the proper balance. Those activities have generated an impressive body of material that would be instructive for new FDA leadership to review. We provide a summary of and links to those documents below (limited to WLF’s FDA-related work product in the past several years) to simplify access to that work product. Continue reading
Featured Expert Contributor — Corporate Governance/Securities Law
Stephen M. Bainbridge, William D. Warren Distinguished Professor of Law, UCLA School of Law.
Section 1502 of the 2010 Dodd-Frank Act required the Securities and Exchange Commission (SEC) to develop disclosure rules requiring public companies to disclose whether their products contained “conflict minerals.” The minerals in question included cassiterite, columbite-tantalite, gold, wolframite, or their derivatives, all of which are used in a variety of common products, including computers, smart phones, and other everyday technology. In order to be deemed conflict minerals, they had to be sourced from the Democratic Republic of the Congo (DRC) or its adjoining countries. Continue reading
On the eve of the inauguration, many industries and businesses await the changes a new administration will bring. In particular, payday lenders are hoping that they will once again be able to enjoy unrestricted banking access, as for the past several years their banking relationships have slowly been severed as a result of a government initiative known as “Operation Choke Point.”
Operation Choke Point began—without any Congressional approval or even knowledge—as a product of President Obama’s 2009 executive order to eliminate fraudulent and illegal businesses. Not surprisingly, however, the initiative quickly expanded. By 2013, the Department of Justice (DOJ) had started quietly launching the now-infamous federal initiative unconstitutionally cutting off countless legitimate businesses from banking services. Continue reading
On November 10, 2016, a California federal judge dismissed a putative class-action lawsuit designed to force the Classifications and Rating Administration (CARA) to give an “R” rating to any film containing tobacco use. Alleging that around 200,000 young people would start smoking every year after seeing tobacco use in G, PG, and PG-13 rated movies, the plaintiff in Forsyth v. Motion Picture Association of America, Inc. sued the Motion Picture Association of America (MPAA) (CARA is operated as a division of the association), the National Association of Theater Owners, and various major movie studios. Because injunctive relief alone isn’t enough in most class actions, the complaint also sought $20 million in damages. Continue reading
When prohibiting or reducing “harmful” economic conduct proves either politically unpalatable or otherwise unachievable, governmental regulators often target speech about the conduct as a convenient alternative. Rather than ban the sale of tobacco or sugary drinks, for instance, federal, state, and local governments have imposed restrictions on advertising and other promotional speech. Unable to generate support for a second Prohibition, temperance proponents have attempted to chill alcohol consumption through speech limits, such as proscribing disclosure of alcohol-by-volume percentage on beer labels and even censoring ads for happy hours. In 2016, the so-called sharing economy became the government’s latest target regulating conduct by proxy. Thankfully, online short-term rental platforms like Airbnb are fighting back with First Amendment challenges. Continue reading
Today, the US Food and Drug Administration (FDA) will hold a long-awaited public meeting to consider how off-label information about medicines can be shared with physicians. Washington Legal Foundation staff attorney Greg Herbers will testify at the meeting, which FDA has entitled “Communications Regarding Unapproved Uses of Approved Medical Products.”
Since WLF’s landmark victories in the Washington Legal Foundation cases, courts have consistently upheld the First Amendment right to communicate truthful and non-misleading information about the off-label uses of medical products. For instance, in US v. Caronia, WLF represented an industry employee convicted of discussing a drug’s off-label benefits and won a reversal from the US Court of Appeals for the Second Circuit on First Amendment grounds. WLF filed an amicus brief in a second case, Amarin Pharma v. FDA, in which a US federal district court followed the rationale of Caronia. Those decisions presumably played a major part in FDA’s decision to reevaluate its approach to off-label communication.
The text of WLF’s testimony is available here. WLF will also submit written comments to FDA in December.