WASHINGTON, Jan. 12,
2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc.
(Vanda) (Nasdaq: VNDA) submitted a comment letter (here) on
January 5, 2024, regarding the FDA's
recently announced policy—by way of a draft guidance document—that
substantially restricts drug manufacturers' ability to communicate
truthful, non-misleading information about FDA-approved drugs.
Communication of novel scientific findings and emerging
therapies is crucial to inform healthcare providers about new
treatment options that did not exist at the time of their medical
training. Innovators who conduct this research play a significant
role in communicating this new information to healthcare providers.
The FDA's guidance document, Communications From Firms to Health
Care Providers Regarding Scientific Information on Unapproved Uses
of Approved/Cleared Medical Products (October 2023), threatens drugmakers with
criminal misbranding liability when they share truthful,
non-misleading scientific information about unapproved uses of
FDA-approved drugs—like the results of a new clinical trial—with
healthcare providers unless the communication satisfies vague and
nebulous FDA standards for both form and scientific substance. The
FDA's assertion of such broad authority to censure the scientific
information that drug manufacturers may share with healthcare
providers—doctors and others who are working tirelessly to find
innovative solutions for individual patients suffering from a wide
range of afflictions—is of grave concern, as it encroaches on
freedom of speech, hastily attempts to coerce manufacturers into
compliance without due process, and imposes rules without clear
direction from Congress in addressing major questions that broadly
affect the practice of medicine and public health.
Vanda's comment argues that there are four problems with the
FDA's approach:
- The FDA's guidance imposes content-based burdens on drugmakers'
protected commercial speech in violation of the First
Amendment.
- The FDA's standards are too vague to satisfy the minimum
requirements of due process.
- The Federal Food, Drug and Cosmetic Act does not give the FDA
the authority to regulate marketing of approved drugs for off-label
use.
- The FDA's guidance in fact sets binding standards, even though
the FDA describes the guidance as a "nonbinding statement of
policy."
Vanda's full comment is publicly available and also on
Regulations.gov here.
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on
the development and commercialization of innovative therapies to
address high unmet medical needs and improve the lives of patients.
For more on Vanda Pharmaceuticals Inc., please visit
www.vandapharma.com and follow us on Twitter @vandapharma.
Corporate Contact:
Kevin
Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.