Legal questions swirl about off-label use of medications

CONSUMER FORUM

Posted Aug. 23, 2015, at 1:38 p.m.

Maine is among the states that will share in a $71 million settlement of the lawsuit against drug manufacturer Amgen.

Click image to see other Off-Label decisions on the DOJ site

The states bringing the suit alleged Amgen promoted biologic medications Aranesp and Enbrel for off-label uses. Their complaint said the company promoted the use of Aranesp for longer periods than the U.S. Food and Drug Administration approved.

The complaint also charged that Amgen claimed Aranesp could fight anemia caused by cancer without having either FDA approval or scientific research to support that claim.

The complaint said the company also promoted Enbrel as effective in treating mild plaque psoriasis; the FDA has approved use of the drug only to treat chronic-moderate to severe plaque psoriasis. The complaint also charged that Amgen overstated the length of time Embrel was effective in treating psoriasis.

The settlement was announced last week by several state attorneys general. In a statement, Amgen said the settlement resolves some of the same matters as in a 2012 settlement with the federal government. Under the settlement with the states, Amgen did not admit any wrongdoing or liability.

Maine also was a party to the December 2012 settlement. A U.S. Department of Justice news release at that time said the company paid $612 million to resolve lawsuits under the False Claims Act and $150 million in criminal penalties and forfeiture.

In its statement sent to Northeast CONTACT, Amgen said, “separate state and federal resolutions of the same underlying issues is the normal practice in such legal matters.”

The company added it has a “strong compliance program, and our management is dedicated to fostering a culture of doing the right thing at Amgen in full compliance with the law.”

The company also says all Aranesp-related conduct that riled regulators took place during the years 2002 and 2007; it says all Enbrel-related conduct happened between 2004 and 2011.

Over the years, pharmaceutical companies have handed over billions of dollars to settle claims of misbehavior. Federal regulators don’t want drug company reps talking to doctors about off-label uses of drugs; manufacturers have maintained they should be able to have such conversations, as long as they are truthful.

In May, Amarin Pharma filed suit against the FDA, saying it had a constitutional right to share information with doctors. Lawyers for the company say they believe it is the first time the FDA has been sued pre-emptively over the free speech issue.

Floyd Abrams, attorney for Amarin, put it this way in an interview with Business Day: “If you tell the truth — if you’re not misleading — then the First Amendment protects you when you provide this sort of information.”

Dr. Michael Carome of the advocacy group Public Citizen holds the opposite view.

“If this lawsuit were to succeed, it would be devastating for drug safety and undermine the drug approval process,” Carome said.

If it goes that far, a court might rule either broadly or narrowly, making an outcome tough to predict. Consumers can best protect themselves by carefully reading the data sheets that come with their prescription meds. If what your doctor tells you doesn’t match the intended uses in the instructions, start asking questions.

Consumer Forum is a collaboration of the Bangor Daily News and Northeast CONTACT, Maine’s all-volunteer, nonprofit consumer organization. For assistance with consumer-related issues, including consumer fraud and identity theft, or for information, write Consumer Forum, P.O. Box 486, Brewer, ME 04412, visit https://necontact.wordpress.com or email contacexdir@live.com.

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: