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FEDERAL REGULATORY READING LIST: Resources for New FDA Drug and Device Regulators

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

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Latest Litigation
In re: Reconsideration of Pay-Ratio Rule Implementation
On March 24, 2017, WLF filed formal comments with the U.S. Securities and Exchange Commission in response to acting Chairman Michael S. Piwowar’s request for input on the implementation of the Pay-Ratio Disclosure Rule. SEC adopted the rule in...
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Fox Television Stations, Inc. v. FilmOn X, LLC
On March 21, 2017, U.S. Court of Appeals for the Ninth Circuit overturned a trial court decision that would have legitimized a business model based on the unauthorized, for-profit exploitation (via the Internet) of the copyrighted works of others....
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NLRB v. SW General, Inc.
On March 21, 2017, the U.S. Supreme Court rejected the previous administration’s reading of a federal law designed to prevent presidents from evading the Senate’s constitutional advice-and-consent function. The decision marked a victory...
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In re: Conflict Minerals Rule
On March 17, 2017 WLF filed comments with SEC in response to Acting Chairman Piwowar’s January 31 request for input on the Conflict Minerals Rule. WLF seeks repeal of the rule, which implements § 1502 of the Dodd-Frank Wall Street Reform...
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Bristol-Myers Squibb Co. v. Superior Court
On March 8, 2017, WLF filed a brief in the U.S. Supreme Court, urging it to require state courts to comply with due-process limits on their authority to exercise personal jurisdiction over out-of-state defendants. WLF argued that although a 2014...
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BNSF Railway Company v. Tyrrell
On March 6, 2017, WLF filed a brief in support of BNSF Railway Company’s challenge to a Montana Supreme Court decision that would permit state courts to exercise personal jurisdiction over out-of-state defendants—in violation of the...
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Latest Publications
Colorado Court Should Find State Law Preempts Boulder County’s Oil and Gas Development Moratorium
By Jason Dunn, who chairs the Political Law Group and Attorneys General Practice Group at Brownstein Hyatt Farber Schreck LLP in Denver, CO, and Julia Rhine, an Associate in the firm’s Natural Resources Department.
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Penalty Disparities Frustrate Protection of Consumers from Dangerous Counterfeit and Diverted Drugs
By Sheldon Bradshaw, a Partner in the FDA and Life Sciences Practice Groups at King & Spalding LLP in Washington, DC, who served as FDA Chief Counsel from 2005-2007. 
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First Amendment Limits Government’s Power to Compel Commercial Speech
By Jonathan F. Cohn, a Partner with Sidley & Austin LLP in Washington, DC, and Paul J. Ray, an Associate with the firm.
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Latest Communication
 
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