OTC statins vetoed again by FDA panels

Several panelists recommend that the agency explore the intermediate approach of allowing pharmacists to supervise statin sales.

By Susan J. Landers — Posted Jan. 31, 2005

Print  |   Email  |   Respond  |   Reprints  |   Like Facebook  |   Share Twitter  |   Tweet Linkedin

Washington -- The latest effort to sell a cholesterol-lowering statin over the counter met with defeat on Jan. 14 when two Food and Drug Administration advisory panels voted jointly 20-3 against a proposal by Merck & Co. and Johnson & Johnson to sell 20 mg tablets of Mevacor directly to consumers without a prescription.

The FDA generally heeds the advice given by its panels.

Despite the lopsided vote, several panelists urged the drug companies not to give up their efforts, because the benefits of lower cholesterol levels are clear. And many who voted against the proposal said they favored an approach taken in Great Britain last year when it allowed over-the-counter sales of 10 mg of Zocor but only under the supervision of a pharmacist. The British system allows for this intermediate supervision while the FDA doesn't have that option.

Another proposal for OTC sales of a second statin is expected to be heard later this year.

The vetoed proposals are the second attempts by pharmaceutical companies to gain OTC status for their statins. Both were rejected by the FDA in 2000. OTC approval allows a manufacturer to obtain a three-year exclusive right to sell the drug.

Many of the panelists on the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee also said they thought that the drug presented such a significant danger, particularly to a fetus, that a physician's supervision should continue to be required.

Concerns were also raised about the ability of people to determine on their own whether they should take a statin. The drugs, while generally safe, can cause muscle pain and the more serious muscle breakdown rhabdomyolysis that can lead to kidney and other organ damage.

The AMA strongly opposes OTC statin sales and wrote in a letter to the FDA dated Dec. 22, 2004, that to lose the benefits of physician supervision would be detrimental to the health of many individuals.

The AMA also opposes the addition of a third class of drugs that would be controlled by pharmacists, again citing patient safety considerations.

Back to top



Read story

Confronting bias against obese patients

Medical educators are starting to raise awareness about how weight-related stigma can impair patient-physician communication and the treatment of obesity. Read story

Read story


American Medical News is ceasing publication after 55 years of serving physicians by keeping them informed of their rapidly changing profession. Read story

Read story

Policing medical practice employees after work

Doctors can try to regulate staff actions outside the office, but they must watch what they try to stamp out and how they do it. Read story

Read story

Diabetes prevention: Set on a course for lifestyle change

The YMCA's evidence-based program is helping prediabetic patients eat right, get active and lose weight. Read story

Read story

Medicaid's muddled preventive care picture

The health system reform law promises no-cost coverage of a lengthy list of screenings and other prevention services, but some beneficiaries still might miss out. Read story

Read story

How to get tax breaks for your medical practice

Federal, state and local governments offer doctors incentives because practices are recognized as economic engines. But physicians must know how and where to find them. Read story

Read story

Advance pay ACOs: A down payment on Medicare's future

Accountable care organizations that pay doctors up-front bring practice improvements, but it's unclear yet if program actuaries will see a return on investment. Read story

Read story

Physician liability: Your team, your legal risk

When health care team members drop the ball, it's often doctors who end up in court. How can physicians improve such care and avoid risks? Read story

  • Stay informed
  • Twitter
  • Facebook
  • RSS
  • LinkedIn