Public reaction has been overwhelmingly against proposed U.S. Food and Drug Administration guidance that would allow pharmaceutical companies to market their drugs with information that would contradict the FDA’s approved drug warnings. Frankly, the manner in which Janssen marketed the antipsychotic Risperdal, which resulted in the imposition of criminal and civil penalties, may very well have been a case in support of those opponents.
In response to petitions of 11 pharmaceutical corporations, the FDA proposed in June 2014 guidance that would allow drug makers to use conflicting studies that understate risks contained on product labeling in order to promote a drug to the health care profession.
“Unfortunately, the draft guidance strikes the balance more toward the industry’s view of its First Amendment right to commercial speech than toward the agency’s mandate for patient protection,” Dr. Sidney M. Wolfe wrote in an article that the journal JAMA Internal Medicine released on Aug. 15, 2014.
Wolfe suggested instead in 2014 that the FDA should take the following action: “To protect patients and the public health, the FDA should substantially revise its draft guidance for industry on distributing medical publications about the risks of prescription drugs and biological products. When new information supports a reduction in risk, the company should inform the FDA and provide the evidence, as is required under current regulations; if the agency is convinced, the label can be changed. Off-label risk reduction is a misguided approach.”
Wolfe is the founder and senior adviser of Public Citizen’s Health Research Group. The group obtained the public comments that the FDA received in regard to the proposal, and it released a rebuke on March 11 of this year.
“After the agency closed the comment period in August, only one of the 1,782 comments submitted on the proposal was posted on the FDA’s website,” reads Public Citizen’s March 11 statement. “On Oct. 15, Public Citizen requested under the Freedom of Information Act the full text of all the comments. After obtaining the comments, Public Citizen read each response, finding only 11 commenters – less than 1 percent – in support of the proposed FDA guidance. The 11 comments came from pharmaceutical companies and their trade associations, along with a single academic.”
Wolfe summarized public response this way last month: “As predicted, the proposal’s few supporters primarily are industry companies and their associations, all of which would benefit from being allowed and encouraged to sell more of their products by making them seem safer than the FDA has judged them to be.”
On the same day that Public Citizen issued its release, the organization sent a letter to U.S. Health and Human Services Secretary Sylvia Mathews Burwell. In the letter, Public Citizen repeated its October 2014 call to pull the plug on the draft guidance.
One of the public comments came from a Carol Hudson, who wrote, “When being prescribed drugs by my physician, I need to hear scientific reasons why the drugs will help me and I also need to know all the side effects and risks of the drug. What I DON’T [her emphasis] need is to have pharmaceutical corporations push merchandising on my doctor and on me, withholding warnings that could save my life and my health.”
Ironically, as the law now stands, misrepresenting drug risks can land a drug company in deep trouble. That was what happened to Johnson & Johnson and its Janssen subsidiary, which agreed with the U.S. Justice Department in 2013 to pay more than $2.2 billion in criminal and civil penalties “arising from allegations relating to the prescription drugs Risperdal” and two other medications.
As the Justice Department explained in a Nov. 4, 2013, statement, “[F]rom 1999 through 2005, Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities. The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production. Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients.
“Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism. Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.”
Men and boys have developed female-like breasts allegedly as a result of using Risperdal. The condition is known as gynecomastia. More than 1,200 Risperdal lawsuits have been filed by the drug’s victims.
The Risperdal Litigation Team at Reich & Binstock is investigating the claims of many of these victims and is fighting for justice on their behalf. All one must do, in order to get an experienced Risperdal attorney at Reich & Binstock to determine all of the legal options, is request a free consultation. The law firm operates in all 50 states. Contact Reich & Binstock either by calling the toll-free number below or by submitting an electronic message through this website.
