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FDA Could Approve More Rx to OTC

FDA Could Approve More Rx to OTC

“Pharmacist diagnosis and OTC treatment is not a bad alternative.”

-Bob Ehrlich

In a move causing significant debate and emotion, the FDA is considering making more Rx drugs available. FDA held a hearing March 22-23 on the subject. They have the comment period running through this week. The goal of FDA is to review chronic categories where OTC availability may make it easier to start therapy because a doctor visit would not be needed.

The FDA believes that increasing access might be worth the risk of approving more OTC drugs. It is clear they know that our current medical system cannot handle the diagnosis and treatment of all the sufferers of chronic disease such as high BP or high cholesterol. Having a different way of getting the drugs may help those patients who do not see a doctor get those drugs.

The usual arguments were made at the hearing. The physician side warns that it is dangerous to diagnosis these conditions without the skilled physician interpreting the BP or blood lipid diagnosis. Pharmacists argue that they can do simple diagnostic procedures and counsel patients on how to take the drugs and follow lifestyle changes.

In the ideal world all people would get to see a doctor and have continued follow-up care. In our world that is not the case. Millions of people suffer undiagnosed or untreated hyperlipidemia and high blood pressure. The public policy question is will OTC status and more pharmacist involvement lead to healthier people? Physicians argue that some underlying conditions will be missed or that a more urgent serious problem is behind a high blood pressure or cholesterol number.

I think we need to deal with the real world of limited access. These newly insured under Obamacare have problems getting to see a doctor. If they can visit a pharmacist to have blood sugar, blood pressure and lipid profiles done and then buy some OTC meds, we may see better outcomes. We need to be realistic how a doctor treats most patients. They do not do a deep analysis of test results. If BP is higher than 140/90 they are likely to suggest a mild diuretic or something stronger. If blood sugar is over 120 they may suggest diet and eventually an oral pill. My point is most doctors do not discover some deep seeded issue under the test numbers. They do not connect all the unseen dots like Dr. House.

A pharmacist could do basic testing and counseling faster and cheaper. At least having OTC’s makes the chance of getting treatment easier. The patient dilemma is that once a drug goes OTC, insurance companies may no longer cover it. In the case of more OTC’s, patients may pay more for drugs. On the other hand competition will drive down prices and store brands will undoubtedly be offered at cheap prices. More OTC’s may keep our insurance premiums in line as payers would have less drug payments.

The problem of whether to allow more OTC’s largely depends on the risk/benefit. While it would be nice for everyone to see a physician, we may not be able to make that happen. For common chronic conditions pharmacist diagnosis and OTC treatment is not a bad alternative. People generally like their pharmacist and they have access to one easily. So I hope FDA is aggressive in looking at new ways to diagnose and treat Americans who have trouble seeing a doctor. I see a lot more benefit than risk in opening up more drug categories to OTC status.

Bob Ehrlich, Chairman

DTC Perspectives, Inc.

Bob Ehrlich
Chairman & Chief Executive Officer at DTC Perspectives
Bob Ehrlich has over 20 years marketing experience in pharmaceutical and consumer products. Bob is the CEO of DTC Perspectives, Inc., a DTC services company founded in 2000. DTC Perspectives, Inc. developed the DTC National Conference, the largest DTC conference in the industry. DTC Perspectives, Inc. also publishes DTC Perspectives, a quarterly journal dedicated to DTC issues and practices. In addition DTC Perspectives, Inc. does DTC consulting for established and emerging companies, and provides DTC marketing plans for pharmaceutical companies.
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