FDA to Review “Free Speech” for Off-Label Drug Marketing

Off-Label Drug Marketing Argues “Free Speech,” FDA to Review Drug Safety Guidelines

off-label drug marketingOff-label drug marketing has created huge controversies with major pharmaceutical manufacturers, leading to pharmaceutical lawsuits against drugs like migraine drug Topamax, or antipsychotic Risperdal. Doctors and patients who prescribed or used drugs for off-label uses can suffer serious side-effects, and because the side-effects for their case are not on the label, many times these patients file personal injury or class actions lawsuits alleging negligence and failure to warn on the part of the pharmaceutical company.

For decades, the FDA has agreed with patients and doctors: sales pitches from drug marketers must be factual, backed up by scientific research, and only include uses for which the FDA has approved the drug. To do so endangers patients, the federal agency argues, and the US Department of Justice backs the safety regulator up by busting pharmaceutical companies that violate such laws.

However, with several recent federal court decisions, the FDA stated that it would begin to review guidelines for off-label drug marketing uses, including what information drug marketers can distribute to doctors when they discuss the latest patented medication.

Critics of the current rule system state that changing the rules would allow physicians access to better information, based on the most recent scientific studies conducted by the pharmaceutical company. Other critics, of pharmaceutical companies, believe that the companies would exploit even a small loosening in the restrictions just to make money, by promoting drugs for off-label uses where the drug offers no benefit.

Pharmaceutical companies regularly petition the FDA for clearer guidance on off-label regulations. While the FDA and the DOJ both state that promoting off-label use is “misbranding,” prescriptions for certain drugs under Medicare allow for some off-label treatments, which pharmaceutical companies claim is confusing. In addition, some recent court rulings allow for companies’ right to free speech in their marketing practices, which can include off-label drug marketing.

If First Amendment legal challenges are successful in court, the rulings “would turn back FDA’s proactive role in American medicine and jeopardize the safety of patients, as well as the future of innovation and medical progress,” FDA Commissioner Margaret A. Hamburg said in a 2010 speech.

However, off-label use brings up a host of potential medical problems, including serious personal injury and death from dangerous side effects that doctors or patients don’t know about.

“It’s hard to know what’s legitimate and what’s not,” said Michael Wilkes, a medical professor at the University of California at Davis who has written about drug promotion. “I’d like to see [the FDA] err on the side of overregulation and making companies prove that these drugs work” for off-label uses.

Regardless, pharmaceutical companies claim that they conduct scientific research all the time, and that freedom of speech would allow them to discuss their latest findings with doctors to promote a drug’s use without off-label offenses.

“In the ideal world, clinical trials would be quick, easy to conduct and free. Unfortunately, none of those conditions are true,” said Jeff Francer, vice president and senior counsel at the Pharmaceutical Research and Manufacturers of America. “Depending on where a drug is in its life cycle, it may not make economic sense for a company to pay for years of clinical study when the medicine is going to lose its patent in a short amount of time.”

“Right now, the FDA essentially prohibits the communication of large swaths of information that is truthful and not misleading,” he said. “That information can be extremely beneficial.”

“Our fiduciary responsibility is to our patients. This isn’t about profits. It’s really about patient safety,” Wilkes said. “As a rule, we ought to be offering our patients treatments and cures and interventions that have been proven to work.”

The Strom Law Firm Can Help with Dangerous Drug Cases

The Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous prescription drugs and medical devices promoted for off-label uses. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs or medical products such as Lidoderm, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800



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