April 9, 2007
The United States Senate
Committee on Health, Education, Labor and Pensions
428 Senate Dirksen Office Building
Washington, DC 20510
Dear Members of the Committee:
The undersigned organizations write in support of the intent of the Safe Drug Compounding Act of 2007. The Act seeks to establish protections for the public to ensure safe use of compounded drugs. We also strongly urge revisions to the act that we believe will better safeguard the public health.
The practice of pharmacy compounding has grown dramatically in recent years, and as practiced today exposes users to risks from products that have not been tested for safety or efficacy. Moreover, compounding pharmacists are not required to meet the Food and Drug Administration’s Good Manufacturing Practices standards to assure content, potency, purity and stability.
Without oversight, compounding pharmacy companies are engaging in large-scale manufacture and wide-spread marketing of prescription drugs and biologics. This marketing includes misleading and unsubstantiated claims about the safety and efficacy of compounded drugs. The promotion of bio-identical hormones for women at menopause is one such example. Although the FDA does not track problems resulting from this practice, our concern about the danger it poses is supported by numerous media reports of injury and death from compounded drug products.
“Traditional” compounding for individual patients by individual pharmacists has a legitimate, but rare, role in today’s pharmacy practice. But such small-scale practice is a far cry from the industry that has developed in the United States since the 1980’s and which is reputed to consist of 800 to 900 pharmacy compounders with reported sales in excess of $2 billion annually.
While we support the intent of the Safe Drug Compounding Act of 2007, we strongly urge that the act be amended to reflect the following principles:
- Compounded products should not be subject to an FDA approval process distinct from that which is currently used to approve new drugs. The Act proposes creation of a second drug approval process with a much lower standard than that currently applied to new drug applications. It would allow for sale of new products and entities never before approved in the U.S. based solely on evidence from published medical literature, without the submission of clinical trial data to be reviewed independently by the FDA. This is not an adequate standard for approval, particularly in light of recent studies indicating that the integrity of published medical literature is often compromised by the author’s financial conflicts of interest, by the agenda of manufacturer sponsors and by the routine withholding of safety data. There is evidence as well that the studies that report a finding of efficacy are much more likely to be published in peer review journals than those that do not.
- Disclosure statements for patients should be concise, understandable and accurate. The following is an example of what we would support: This drug has not been tested for safety and effectiveness and is not approved by the FDA for any purpose. This drug was not produced under conditions meeting FDA Good Manufacturing Practice guidelines to assure its contents, potency, purity and stability.
- The disclosure statement for patients should be in the form of a generic medication guide that FDA should require is provided to consumers with each new and refill prescription.
- The Act must establish enforcement provisions, including the authority to levy punitive penalties as appropriate.
If we can provide more information or be helpful in any other way, please contact us. The contact information is provided below.
Center for Medical Consumers
National Consumer League
National Research Center for Women and Families
National Women’s Health Network
Our Bodies Ourselves
Contact: Arthur Levin, Center for Medical Consumers, 212 674 7105 x31 or firstname.lastname@example.org