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.
Truthful Manufacturer Speech
No medical product may be distributed or sold in the United States unless FDA has approved the product as safe and effective for its intended use and has approved the product labeling. But FDA has no authority to regulate how approved products are actually used. Indeed, post-approval research regularly demonstrates that these products are safe and effective for uses not explicitly specified in the FDA-approved labeling, and doctors routinely rely on that research to prescribe drugs and devices for such “off-label” uses. While peer-reviewed off-label information circulates widely in the scientific community, FDA has sought to prevent manufacturers from disseminating such information about their own products—often without regard to the truthfulness of that information.
Ever since WLF obtained a permanent injunction against FDA in 1998 that bars the agency from suppressing truthful manufacturer speech in at least some instances, the extent to which FDA speech-suppression efforts are compatible with the First Amendment has been hotly debated. WLF has led that debate—in the courts, in administrative proceedings, and in the court of public opinion. Most prominently, WLF played a lead role in FDA’s most significant defeat on this issue, the Second Circuit’s 2012 decision in United States v. Caronia—in which WLF filed a brief and presented the oral argument on First Amendment issues on behalf of a pharmaceutical salesman charged criminally with providing truthful information about off-label uses of one of his company’s drugs. WLF also filed a brief in another significant First Amendment defeat for FDA, 2015’s Amarin v. United States. When FDA threatened to sanction yet another manufacturer for speaking truthfully about its products, WLF filed a brief (in Allergan v. United States) supporting that manufacturer’s First Amendment challenge to those sanctions.
WLF has regularly filed formal comments with FDA on speech issues, pointing out First Amendment objections to many of the guidances and rules adopted by FDA in its efforts to suppress manufacturer speech. These include:
- Response to FDA request for suggested changes in its policies governing off-label communications regarding FDA-approved medical products (Dec. 30, 2016).
- Response to proposed FDA regulation that would redefine a manufacturer’s “intended use” of an FDA-approved medical product (Nov. 25, 2015);
- Response to FDA draft guidance on social media (e.g., Facebook or Twitter) speech restrictions (Sept. 16, 2014);
- Response to FDA revised draft guidance on distributing scientific and medical publications (May 15, 2014);
- Response to FDA draft guidance regarding restrictions on manufacturer participation in “interactional promotional media” (Apr.14, 2014).
WLF also testified at a November 9, 2016 hearing conducted by FDA, at which the agency sought input regarding potential changes regarding its restrictions on manufacturers’ off-label speech.
WLF’s numerous media briefings and publications supporting manufacturers’ rights to communicate truthful off-label information include:
- Freeing Off-Label Use Information: Three Lingering Questions for Medical Product Innovators and Regulators (WLF Media Briefing, May 2, 2016);
- U.S. v. Caronia, One Year Later: The First Amendment and Federal Oversight of Off-Label Drug and Device “Promotion” (WLF Media Briefing, Jan. 16, 2014);
- Facteau Medical Device Convictions Illustrate FDA’s Unhealthy Control Over Off-Label Speech (WLF Legal Backgrounder, Oct. 28, 2016);
- To Tweet or Not to Tweet: How FDA Social Media Guidelines Violate the First Amendment (WLF Legal Backgrounder, Sept. 25, 2014);
- The First Amendment and the Emerging Tort of Off-Label “Promotion” (WLF Working Paper April 2013).
The Federal False Claims Act
The False Claims Act (FCA) is a federal statute that makes it crime to “knowingly present, or cause to be presented [to the federal government] a false or fraudulent claim” for payment. As part of its campaign to suppress truthful manufacturer speech regarding off-label uses of approved medical products, FDA regularly collaborates with the Justice Department in using the FCA to sue medical-product manufacturers for hundreds of millions of dollars—supposedly to recoup improper Medicaid and Medicare expenditures. FDA’s and DOJ’s usual theory is as follows: by speaking truthfully about off-label uses that may not have been approved for government reimbursement, the manufacturers “caused” third parties (principally, pharmacies and hospitals) to improperly present Medicare and Medicaid payment claims to the government.
WLF regularly participates as an amicus curiae in federal court proceedings to oppose overly expansive readings of the FCA. In Ortho Biotech Products, L.P. v. U.S. ex rel. Duxbury and U.S. ex rel. Hopper v. Solvay Pharmaceuticals, Inc., WLF filed briefs (here and here) urging federal courts to reject FCA claims against manufacturers alleged to have promoted off-label uses of their drugs, in the absence of evidence that the defendants’ conduct actually “caused” anyone to submit an improper reimbursement request to the government. In Universal Health Services, Inc. v. U.S. ex rel. Escobar, the U.S. Supreme Court agreed with arguments, contained in WLF’s brief, that an FCA claim may not proceed to trial unless the government demonstrates that it paid out funds based on a claim that was “materially” false. In Purdue Pharma, L.P. v. U.S. ex rel. May, WLF filed a brief urging the Supreme Court to hold that an individual is not entitled to appoint herself as a private attorney-general and file an FCA suit (on behalf of the federal government) alleging improper off-label promotions of FDA-approved drugs, if the allegations were publicly disclosed before the suit was filed and the individual is not the “original source” of the allegations.
WLF’s recent publications and programs on the False Claims Act include:
- How Exclusion and Debarment Allow Prosecutors to Vastly Expand False Claims Act Liability (WLF Working Paper, Dec. 2016);
- Implied-Certification FCA Claims Post-Escobar: Three Appellate Court Cases May Show the Way (WLF Legal Backgrounder, Sept. 30, 2016);
- The Case for a Clear-and-Convincing Burden of Proof for False Claims Act Qui Tam Relators (WLF Working Paper, Sept. 2016);
- The View From The Front Lines: Litigation Under The False Claims Act In A New Era Of Enforcement (WLF Monograph, Mar. 2013);
- Good Manufacturing Practices Deficiencies: Federal Health Care Enforcers’ Next False Claims Act Target (WLF Web Seminar, June 13, 2013).
Increasingly Restrictive Regulation of Medical Devices
Congress granted FDA authority to regulate medical devices for the first time in 1976. To ensure that FDA’s new regulatory authority did not disrupt healthcare delivery, Congress “grandfathered” medical devices that were already on the market. It further provided that new medical devices that are “substantially equivalent” to pre-1976 devices are also grandfathered. To take advantage of this latter provision, manufacturers need only submit a “510(k) application” for the purpose of demonstrating substantial equivalent. Because this abbreviated application process is so much faster and less expensive than applying to FDA for authority to market an entirely new medical device, the vast majority of medical devices reach the market as a result of receiving 510(k) “clearance” from FDA.
In recent years, in response to concerns of special-interest activists that the 510(k) review process is not sufficiently demanding, FDA has adopted numerous non-statutory requirements that significantly complicate the 510(k) process. WLF has been at the forefront of efforts to eliminate such needless bureaucracy. Among the numerous regulatory proceedings in which WLF has participated in order to oppose more stringent 510(k) requirements are the following:
- Response to FDA draft guidance regarding when it is necessary to submit a new 510(k) for a change to an existing device (Nov. 13, 2016);
- Response to FDA request for comments regarding whether emergency “eyewash” products should be classified as “medical devices” or “drugs”—the latter classification would subject the products to far more extensive FDA approval requirements (Mar. 3, 2014);
- Comments in support of a petition filed by the Minnesota Medical Device Association, urging FDA to streamline its increasingly cumbersome 510(k) application process (Oct. 16, 2013);
- Response to FDA draft guidance that would significantly increase reporting requirements for 510(k) devices (Oct. 11, 2013);
- Response to FDA draft guidance regarding manufacturer reporting requirements for safety-related changes to 510(k) devices (May 23, 2013);
- Response to FDA draft guidance that would classify as “drugs” many medical products previously classified as “medical devices” (Sept. 20, 2011);
- Response to FDA draft guidance that would subject devices not intended for treating patients, but rather for research uses only, to FDA regulation (Aug. 31, 2011).
WLF has opposed FDA efforts to expand its regulation of medical devices in court in cases such as Sottera, Inc. v. FDA, in which we filed an amicus brief in support of a successful effort to prevent FDA from regulating e-cigarettes as “medical devices.”
WLF also filed a petition with FDA, asserting that an advisory committee appointed to investigate possible changes in the medical device 510(k) approval process did not comply with requirements of the Federal Advisory Committee Act and that FDA was thus barred from considering the committee’s advice.
WLF’s numerous programs and publications regarding excessive FDA regulation of medical devices include the following:
- FDA Goes Astray on Device Oversight: Proposed Guidance on 510(k) Review, Adverse Event Reporting, and Recalls (WLF Media Briefing, Oct. 17, 2013);
- FDA’s Device Recall Guidance: Significant Enhancement Required (WLF Legal Backgrounder, Aug, 2, 2013).
Compliance with the Rule of Law
In an apparent effort to accelerate desired reforms, FDA officials have sought to evade some of the procedural requirements imposed by Congress on all administrative agencies. WLF has repeatedly participated in litigation designed to require FDA to adhere to those requirements, thereby ensuring that the views of all interested stakeholders can be heard before the agency takes significant regulatory actions.
Recent WLF litigation activity includes filing briefs (here and here) in Prevor v. FDA, in which the court twice overturned FDA decisions to classify a medical product as a “drug,” in part because FDA failed to comply with procedural requirements imposed by the Administrative Procedure Act (APA); a brief in United States v. Franck’s Lab, Inc., in which the trial court faulted FDA for changing existing regulations without complying with the APA’s notice-and-comment requirements; and two briefs (here and here) in ViroPharma Inc. v. FDA, in support of similar claims that FDA violated the APA.
Publications critical of FDA’s failure to abide by procedural requirements include:
- Guidance Gone Wild?: FDA’s Regrettable Retreat from Legislative Rulemaking (WLF Legal Backgrounder, Oct. 7, 2015);
- Court Ruling Casts Doubt on FDA’s Use of Guidance Documents (WLF Legal Backgrounder, Dec. 16, 2011);
- FDA’s Regulatory Extensions: An Overburdened Agency Assigns Itself New Responsibilities (WLF Legal Backgrounder, June 13, 2008).
Preemption of State-Law Tort Suits
When FDA approves a medical product for distribution and sale, it mandates the product’s precise design and labeling. Federal law prohibits the manufacturer from deviating from that FDA mandate. Yet, when attorneys file products-liability claims under state law on behalf of injured clients, they inevitably contend that the product design and labeling were deficient and that their clients would not have been injured if the manufacturer had adopted a stronger label warning or a different design. Because such suits demand, in effect, that the manufacturer make design and labeling changes that are forbidden under federal law, courts sometimes rule that the state-law tort suits are preempted by federal law and must be dismissed.
WLF regularly advocates in support of such preemption claims. Unfortunately, FDA has blown hot and cold on this issue. During some administrations, FDA has filed court briefs opposing the preemption of tort claims that seemingly conflict with federal law. Indeed, it recently has sought to amend its regulations in an apparent effort to assist tort lawyers seeking to sue drug and device manufacturers.
For the past several decades, WLF has participated in many of the Supreme Court and federal appeals court cases that have addressed preemption issues. WLF filed a brief in 2015 in the Supreme Court, urging it to hear Johnson & Johnson v. Reckis and overturn a massive judgment awarded against a drug manufacturer for failing to include an additional warning on the label of a commonly used pain reliever—even though FDA had previously rejected requests to add the very same warning. In 2013, WLF’s brief requested that the Court hear Medtronic v. Stengel, in which the lower court permitted a failure-to-warn claim against a device manufacturer to proceed to trial—even though a federal statute explicitly bars the assertion of such claims against device manufacturers whose products are labeled in compliance with FDA requirements. In another 2013 case, WLF’s brief requested that the Court hear Novartis Pharmaceutical Corp. v. Fussman, to consider whether federal law preempted recovery of punitive damages in a failure-to-warn claim against a manufacturer that complied fully with FDA labeling requirements. In yet another 2013 case, the Court (in Mutual Pharmaceutical Co. v. Bartlett) agreed with arguments in WLF’s amicus brief that failure-to-warn claims against a generic drug manufacturer are preempted because federal law absolutely bars generic manufacturers from making any unilateral labeling changes.
FDA responded by proposing regulations designed to essentially overturn the Bartlett decision. Its proposed regulation would permit generic manufacturers to make unilateral label changes, and then to seek after-the-fact approval from FDA. Of course, if generic manufacturers were authorized to make unilateral label changes, they could no longer argue that it would be impossible to provide the additional warnings that plaintiffs’ lawyers assert they should have made. WLF filed a series of objections (here) to FDA’s proposal, arguing that the proposed regulations threatened public health because their likely effect would be to provide doctors and patients with inconsistent health warnings regarding different brands of a single drug.
FDA eventually agreed to postpone its proposal indefinitely.
Among the many recent WLF media briefings and publications regarding preemption of state-law tort claims against drug and device manufacturers are the following:
- New Jersey High Court Rejects Generic Preemption Defense When Label Updates “Unreasonably” Delayed (WLF Legal Opinion Letter, Dec. 2, 2016);
- The First Amendment Does Not Undermine the Preemption of Medical-Device Failure-to-Warn Suits (WLF Legal Backgrounder, Feb. 26. 2016);
- Sixth Circuit Affirms Impossibility Preemption of Branded-Drug Design-Defect Claims (WLF Legal Opinion Letter, Jan. 15, 2016);
- Federal Preemption: Origins, Types and Trends in the U.S. Supreme Court (WLF Monograph, Oct. 2015);
- Court Rejects Effort to “Preemption-Proof Medical Device Lawsuits (WLF Legal Opinion Letter, Apr. 19, 2013);
- FEDERAL PREEMPTION: New Developments and Notable Trends for Drugs and Medical Devices (WLF Media Briefing, Sept. 16, 2015);
- FDA’s Generic Drug Labeling Proposal: An Unauthorized and Counterproductive Disturbance of the Hatch-Waxman Framework (WLF Media Briefing, Apr. 9, 2014).