U.S. could bring more common drugs over the counter

WASHINGTON Thu Mar 8, 2012 5:23pm EST

U.S. President Barack Obama speaks before signing an executive order directing the Food and Drug Administration (FDA) to take action to help further prevent and reduce prescription drug shortages, protect consumers and prevent price gouging, in the Oval Office of the White House in Washington October 31, 2011. Standing behind Obama is Secretary of Health and Human Services Kathleen Sebelius. REUTERS/Kevin Lamarque

U.S. President Barack Obama speaks before signing an executive order directing the Food and Drug Administration (FDA) to take action to help further prevent and reduce prescription drug shortages, protect consumers and prevent price gouging, in the Oval Office of the White House in Washington October 31, 2011. Standing behind Obama is Secretary of Health and Human Services Kathleen Sebelius.

Credit: Reuters/Kevin Lamarque

Related Topics

WASHINGTON (Reuters) - Prescription drugs to treat some of the most common chronic diseases, such as high cholesterol and diabetes, may become available over the counter under a plan being considered by U.S. regulators.

In what would be a major shift in policy if finalized, the Food and Drug Administration is seeking public comment until Friday on a way to make these medications more readily available. It will also have a meeting about the proposal at the end of March.

The goal is to ensure people take drugs as needed, while still understanding safety issues.

Experts say the unwillingness of people to take certain medications as prescribed has undermined effective treatment of conditions including high blood pressure, raising the cost of healthcare in the United States.

About one in three U.S. adults has high blood pressure, which contributes to heart disease and stroke. The condition cost the United States about $76 billion in 2010, according to the Centers for Disease Control and Prevention.

The FDA said about a third of those with high blood pressure stop taking their medication.

The problem with making these drugs available without a prescription is that many require patients to understand complex aspects of their disease, or exactly when to take a drug to ensure safe use.

A typical over-the-counter drug generally treats short-term conditions with easily recognized symptoms such as a headache or runny nose, and comes with only a factbox or pamphlet.

But taking cholesterol-lowering drugs called statins requires knowledge about a person's elevated or abnormal levels of fat in the blood, known as lipids.

"We've had several applications already to switch statins to over the counter, and they have failed because consumers can't determine their lipid status," Janet Woodcock, head of the FDA's drugs center, told reporters on Wednesday.

The FDA rejected Merck & Co Inc's bid in 2008 to sell its Mevacor statin without a prescription. FDA advisers said patients would not be able to decide for themselves whether they were appropriate candidates for the medicine.

New technology may help change that calculus.

The FDA said it met with drugmakers to discuss ways to help people understand drug risks when they go to a pharmacy, such as using self-serve kiosks, touchscreen pads or interactive videos.

The FDA emphasized that consideration of any over-the-counter change is still in the initial stages.

The FDA will discuss its proposal at the public meeting before developing further guidance. Drugmakers would then have to apply for each drug to be in a new category.

(Reporting by Anna Yukhananov; Editing by Maureen Bavdek)

FILED UNDER:
We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of Reuters. For more information on our comment policy, see http://blogs.reuters.com/fulldisclosure/2010/09/27/toward-a-more-thoughtful-conversation-on-stories/
Comments (9)
Sonnyjc9 wrote:
Here in Thailand I can purchase my allergy medication over the counter, I do not need a prescription as in the States. I can also buy OTC ALL my heart medications. Why some of these drugs are restricted in the USA I don’t know as they don’t get you high or space you out. I have to pay a Dr. $50 just to get the scrips. Gets expensive.

Mar 09, 2012 12:23am EST  --  Report as abuse
freshstart222 wrote:
What’s the point in telling us, when you give us no info. on how to comment to the FDA. Apparently, you and the FDA don’t care what we think.

Mar 09, 2012 5:06am EST  --  Report as abuse
This sounds a little too much like an increased cost here in the US to the consumer. For those that have prescription drug plans, this would become an out of pocket expense. What would the costs like like then? For generic drugs it might not amount to much but I would like to know the facts.

Mar 09, 2012 5:54am EST  --  Report as abuse
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.