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Why does FDA keep drugmakers from informing doctors?

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Manhattan Institute's Paul Howard, director of the Center for Medical Progress, and Jim Copland, director of the Center for Legal Policy, joined forces to author an article on the federal government's criminal prosecution of truthful speech about off-label pharmaceuticals.

The piece can be found in today's Investor's Business Daily:

Every day, millions of Americans benefit from drugs their physicians prescribed for uses and indications beyond those listed on the drug's FDA-approved label.

Some of these off-label uses include treatment for diseases or symptoms, or patient population (like children), not formally reviewed by the Food and Drug Administration. Off-label drug prescribing has been a boon to public health and continues to grow.

A 2006 study in the Archives of Internal Medicine estimates that 21% of commonly used drugs are prescribed for off-label uses.

Doctors find off-label drugs particularly valuable in life-threatening emergencies: 36% of all drugs used in intensive care units are for off-label indications, according to a 2011 study in the Journal of Critical Care. Off-label prescriptions of anti-psychotic drugs alone amounted to an estimated $6 billion in 2008.

Yet Americans may be missing out on new applications for drugs because the law makes it difficult for pharmaceutical companies to share this information with physicians.

Continue Reading at Investors.com.

1 Comment

There are forces in the FDA and the larger regulatory framework of the federal government which want to eliminate all uses of drugs for which there are no "evidence based" studies to justify usage. This includes most off-label uses.

In general there will be a "school of thought" which has studied the off-label use and can provide guidelines. These studies are available in peer reviewed journals of wide circulation. The information is also available at medical meetings and conferences. Whether the drug manufacturers should be involved disseminating this information is an open question.

No doubt, there are drug manufacturers who want to take the old, cheap drugs off the market and reintroduce them as "very expensive newfangled medications." The FDA is the regulatory agency that gets this done. There are a lot of examples where a drug that had been around since Moses was a pup and cost a few cents a pill has been removed by the FDA, only to be re-introduced by some drug company at $20 or $50 or $100 a pill. And there will be a series of new studies to show it is just dandy. And much better than the old off-label use. So the FDA is happy.

Of course, this will only get worse under ObamaCare as all these corporate giants turn into corporate monsters feeding at the government hog trough, paying to play.

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Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.