Citizen Petition to the US Food and Drug Administration to Change Prescribing Guidelines: The Metformin Experience
This article requires a subscription to view the full text. If you have a subscription you may use the login form below to view the article. Access to this article can also be purchased.
The First Amendment to the US Constitution guarantees “the right of the people...to petition the Government for a redress of grievances.” When it comes to the regulation of drugs and protection of public health, individuals have the right to address their concerns by directly petitioning the US Food and Drug Administration (FDA). Any person (including a non-US citizen) can request that the FDA “issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action.” Although healthcare professionals rarely submit such petitions, they can exert a powerful impact on the labeling requirements for drugs.
Metformin is one such example. Metformin is widely accepted as the first-line drug for the treatment of type 2 diabetes mellitus. It effectively lowers hemoglobin A1c levels by 1% to 2% and is weight neutral, safe, and inexpensive. Moreover, one trial demonstrated that it reduces cardiovascular disease complications in patients with newly diagnosed type 2 diabetes mellitus. When metformin was first approved in 1994, it was contraindicated in patients with heart failure and in those with elevated creatinine levels because of concerns about lactic acidosis. This restriction on drug use usually necessitated a switch from metformin to a glucose-lowering agent in a different category, one that frequently carried other risks (such as hypoglycemia), appreciably increased cost, or both. In 2006, the FDA eliminated the heart failure contraindication in response to 2 observational studies.1 These studies suggested that metformin is safe and may actually confer mortality benefits in patients with heart failure.1 However, the contraindication in patients with elevated creatinine levels remained unchanged. Since then, concerns over lactic acidosis have been examined and found to be largely unfounded unless kidney disease is advanced. On the basis of the available data, metformin can be used safely …