Medical Billing Outsourcing Companies

Off-Label Marketing Guidelines

The Department of Health and Human Services (HHS) was recently accused by two House Republicans for the holding up of off-label marketing guidelines by FDA. The lawmakers sent a letter to the HHS Secretary, Sylvia Burwell, stating that they are “perplexed” on the matter, as FDA has neither presented any strategy on off-label marketing, nor held any meeting to discuss the same. They further added that this might make the court’s ruling the determining policy.

Lawmakers believe that the delay is happening because of the dispute among HHS and FDA management. “It is our understanding that HHS has not allowed FDA to issue its completed draft guidance addressing the scope of permissible ‘scientific exchange,’ of useful information about drugs and devices,” they added in the letter. The Republicans also attached a draft bill, which would allow companies sell products for unapproved uses.

Manufacturers complained that the current rules do not allow them to communicate important data to healthcare units on unapproved and off-label use of drugs and devices. Though doctors are free to prescribe medicines for any purpose, which is the off-label use, drug and device companies can only market the ones approved by the FDA.

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HHS Accused For Delay

In response to that, FDA officials said that public health could be compromised if marketing claims did not have sufficient evidence. However, when the Federal court ruling went the other way, FDA promised to come up with new off-label marketing guidelines. They also agreed to schedule a meeting to discuss about the matter. Nevertheless, both the promises by the agency are yet to see any proceedings.

Last month, FDA officials say that they are reviewing the policies, but did not provide any information on when the final guidelines will be released. “After the recent court decisions, the FDA realizes that it must either lead the effort to disseminate off-label information that is truthful, accurate, and non-misleading, or lose its ability to direct the speed, direction, and quality of these communications,” an official said.

As for the draft bill by the Republicans, it might not be presented at the House, a representative said.

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