While the pharmaceutical industry urges the Food and Drug Administration (FDA) to delay a new rule on policing off-label promotion, Arizona has become the first state to pass a law for off-label marketing.

What was seen as an imprudent decision has now been approved by the state as it allows drug makers to promote their medicines for off-label uses as long as the information provided to doctors is truthful. Arizona is currently the first state in the nation to pass this law in the middle of debate over the FDA’s new rule on policing off-label marketing.

Between public safety and the right to free speech

Based on this law, doctors are authorised to prescribe a medicine for an off-label or unapproved use. Nevertheless, drug makers argue that they are restricted to distribute such information such as reprinting medical studies. Considering free speech is restricted, the companies have been pushing the Congress and FDA to loosen regulations.

In response, the FDA fears that public health will be jeopardised if the promotions go too far. In spite of this, it is considered a significant step for drug makers when they were emboldened by the court in recent years to disseminate off-label information as long as it is truthful and not misleading.

On the other hand, a memo issued by FDA two months ago is said to only summarise key issues regarding the debate and criticised many suggestions made by drug makers and supporters of pharmaceutical marketing, instead of proposing possible solutions. This pushes Goldwater Institute, which hatched the law, to promote the issue through the Free Speech in Medicine Act.

“Curbing the exchange of information about off-label treatments by those with the most knowledge about the drug’s uses, risks, and side effects not only prevents patients from receiving the best possible care; it violates the constitutional right to free speech,” said Christina Sandefur, the executive vice president of the Goldwater Institute.

However, Peter Pitts, a former FDA associate commissioner who leads the Centre for Medicine in the Public Interest funded by the pharmaceutical industry, said, “It’s nice that the Arizona legislature thinks disseminating off-label information is a good thing, but it’s not their jurisdiction to say so.”

Controversies regarding the intended use

Contradictory to the law that advocates free speech, the pharmaceutical industry filed a petition earlier urging the agency to postpone a new rule that says drug makers must update labelling for off-label medicines and make statements about their unapproved uses with reliable information.

Despite its delay in enacting the rule next year in response to the drug makers’ anger, the FDA may, however, review the rule this month in light of patient safety. There is also criticism that the drug companies are constantly lobbying the rule to avoid lawsuits.

Echoing the petition, the drug companies complained that the intended use of medicines is determined by the FDA as the rule proposes. The FDA is said to be given an extraordinarily wide leeway to assess whether illegal promotion occurred, which in turn puts manufacturers to a higher risk of liability for unlawful conduct or threat of prosecution.

As for patients, some off-label drugs may result in side effects for patients even though they can be effective for treating unapproved medical conditions. Drug companies have also constantly got into trouble and faced lawsuits with FDA for off-label marketing or bad side effects.

In a notice, the FDA has stated that some may have misunderstood the limited scope of the proposal but still acknowledged the petition to delay the rule until March 2018.

“Right to Try” campaign

Meanwhile, the Goldwater Institute also backed the controversial “Right to Try” in hope of giving early access of experimental medicines to patients. It is considered as a “relatively modest reform” to undermine the authority of FDA by promoting the right of patients to try unapproved medicines.

Thus far, this law have been approved in 33 states and bills were recently introduced in the US House and the Senate. However, critics commented that these bills are wrongheaded for attempting to cut the FDA out of the process. There are concerns that regulatory oversight would be removed and drug makers would be the ultimate gatekeepers for deciding access to their drugs.

As for now, the revision for FDA’s final rule will be anticipated in determining the regulation of off-label uses in the future. MIMS

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