Parker Waichman LLP

FDA Weakens Off-Label Rules

The U.S. Food & Drug Administration (FDA) has loosened its rules regarding the promotion of off-label drug uses.  According to Reuters.com, drug makers will now be allowed to “advise” doctors of possible unapproved uses of their drugs by distributing journal articles that discuss such uses.  The rule change is already drawing fire from critics of […]

The U.S. Food & Drug Administration (FDA) has loosened its rules regarding the promotion of <"https://www.yourlawyer.com/">off-label drug uses.  According to Reuters.com, drug makers will now be allowed to “advise” doctors of possible unapproved uses of their drugs by distributing journal articles that discuss such uses.  The rule change is already drawing fire from critics of the FDA.

Off-label use is defined as the use of a drug in a way that has not been evaluated by the FDA for approval.  Once a drug has been approved, doctors are allowed to prescribe it in anyway they see fit – even unapproved uses.  But drug makers have been barred from touting off-label uses.  However, there has  been disagreement as to whether that prohibition should extend to the distribution of medical journal articles that discuss unapproved uses.  Guidelines regarding the distribution of such articles expired in 2006, and the FDA has been mulling changes ever since.

According to Reuters, the new FDA guidelines will now make it far easier for drug makers to distribute such articles to doctors.  In announcing the guidelines, the FDA said “public health can be served when health-care professionals receive truthful and non-misleading scientific and medical information on unapproved uses.”

But critics of the FDA say the new guidelines are too lenient and endanger patients.  According to the Associated Press, many are disturbed that drug makers will not have to submit articles to the FDA for review before they can be distributed.  The rules that expired in 2006 had such a requirement.

Rep. Henry Waxman (D-Calif), a frequent FDA and drug industry critic, also questioned the timing of the rule change.  “In the final hours of this administration, political appointees at FDA have given drug companies a long-coveted parting gift,” Waxman told the Associated Press. “This fundamentally undermines the requirement that companies prove to FDA that each new use is safe and effective.”

According to a report on MMMonline.com, the guidance does come with some restrictions.  Any articles distributed to doctors must be kept separate from promotional materials.  The articles also cannot be discussed between sales reps and doctors during sales calls.  Reprints can be distributed at medical or scientific conferences “in settings appropriate for scientific exchange,” but not “in promotional exhibit halls or during promotional speakers’ programs.”

The articles also must come only from peer reviewed journals, and they cannot be false or misleading.  Certain types of articles, including those published primarily for distribution by the manufacturer are off-limits, as are letters to the editor, abstracts, reports of Phase 1 trials in healthy subjects or reference publications that contain little or no substantive discussion, are not allowed, MMMonline said.

The Web site also reported that information in the articles distributed  must be unabridged and cannot be marked, highlighted, summarized or otherwise manipulated by the manufacturer.  The reprints must also be accompanied by a “prominently displayed and permanently affixed statement” noting that the uses discussed are unapproved by FDA and any financial ties between the manufacturer and the study’s authors, said the guidance, MMMonline said.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Thank you very much for your good work, they work very excellently and my case went well. I am very satisfied with Parker Waichman LLP, thank you and I recommend them. They are very kind. I thank Jorge and Maryann for being very kind and always attentive to my case.
La estrella marina
8 months ago
5 Star Reviews 150
i am glad to give a 5 star review for parker waichman and the absolute competent...consummate professional ms. benita rollis. she is capable, friendly and patient and has seen me through the entire process...i am giving 5 stars because of the limit shown above but she has performed at a 10 star level....kudos to ms. rollis and pw ...thanks for all
larry howard
3 years ago
5 Star Reviews 150
Good for the body of lawyers and all the staff, very good team, also congratulate Jorge Peniche for his excellent work, and his way of treating people, very good person.
Carlos Olmedo
5 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038