HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.
![handle is hein.crs/govbagi0001 and id is 1 raw text is:
Drug Price Disclosure to Consumers: Current
Legal Authority and Considerations for
Congress
Updated July 9, 2019
Update: On July 8, 2019, the US. District Court for the District of Columbia held that the Department of
Health and Human Services (HHS) exceeded its statutory authority in promulgating its new rule on drug
list price disclosures. As the court explained, [n]either the [Social Security] Act's text, structure, nor
context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to
disclose list prices. The Rule is therefore invalid. The court ultimately vacated the rule. Because the
court concluded that the agency lacked the statutory authority to issue the rule, the court did not evaluate
whether the rule violated the First Amendment. HHS has not yet signaled whether it will appeal the
decision.
The original post from July 5, 2019 is below.
Drug price transparency measures are a key feature of recent efforts to reduce the escalating prices of
many prescription medications. Some Members of Congress and the Trump Administration are currently
exploring various initiatives intended to demystify drug prices, make patients more savvy consumers of
pharmaceuticals, and, in turn, reduce the costs of these products. Notably, as part of these initiatives, the
Centers for Medicare and Medicaid Services (CMS) recently issued a final rule requiring certain
prescription drug and biological product television advertisements to convey specified pricing
information. This rule has sparked debate, as well as a legal challenge involving two distinct, but related
legal issues: (1) whether the disclosure requirement would run afoul of the First Amendment of the
Constitution, and (2) whether CMS possesses the statutory authority to promulgate this rule under its
general authority to administer the Medicare and Medicaid programs. This Sidebar surveys the latter issue
(see this earlier Legal Sidebar on the first question). In so doing, the Sidebar addresses the Executive
Branch's current legal authority to promote drug price transparency to consumers and explores legislative
proposals concerning drug price transparency currently before the 116th Congress.
CMS Drug Pricing Transparency Regulation
Effective July 9, 2019, the new CMS rule will require direct-to-consumer (DTC) television
advertisements for covered pharmaceutical products to include a textual statement indicating the current
Congressional Research Service
https://crsreports.congress.gov
LSB10323
CRS Legal Sidebar
Prepared for Members and
Committees of Congress](ViewImageLocal?handle=hein.crs/govbagi0001&div=1&collection=&method=preview&ext=.png&size=3)