Chairman Tom Harkin
731 Hart Senate Office Building
Washington, DC 20510
Dear Chairman Harkin:
As members of the Patient, Consumer, and Public Health Coalition, we welcome the opportunity to provide our views on the HELP Committee’s draft proposal on pharmaceutical compounding.
We are very concerned that the draft does not adequately address the public health threats posed by compounding pharmacies and will not do enough to prevent future health care crises. Although it might reduce the likelihood of the deaths from products made by companies such as NECC, it will do little to protect the health and safety of thousands of patients who are unwitting customers of large compounding pharmacies that sell defective oral drugs to treat cancer or other life-threatening diseases, or that sell large quantities of sterile products within a state.
An example of the types of patients that would not be protected by the draft legislation are the cancer patients who received diluted cancer drugs from a Kansas City compounding pharmacy in 2000. We are also concerned about compounders that will avoid FDA oversight by limiting their high-volume sales of sterile products to a single state. The risk posed by sterile compounded products, or any other high-risk medical products, does not change based on whether or not the product crosses a state line.
We are concerned that the draft proposal too narrowly defines compounding manufacturers and does not give the FDA adequate authority to regulate compounding manufacturers.
In addition, the draft proposal does not give the FDA access to records of companies that define themselves as traditional compounders, making it next to impossible for the FDA to identify compounding manufacturers that have misrepresented themselves as traditional compounders. This is particularly worrisome because the FDA now attempts to obtain the records and inspect any pharmacy which has been the subject of complaints. Pharmacies have challenged the FDA in court, but the agency has been able to prevail in some cases. This legislation could potentially reduce the agency’s current authority.
We strongly urge you to ensure that the final legislation clarifies and enhances the FDA’s authority to regulate compounding pharmacies that have the potential to harm thousands of patients, even if they do not meet all three criteria for non-traditional compounding manufacturers set forth in the current draft version of the bill.
Below are our comments on specific sections of the draft proposal:
Compounding Manufacturer (page 2)
We agree that compounding manufacturers should be regulated by the FDA. However, the definition of compounding manufacturer is too narrow. It requires that entities meet all three of the following criteria: 1. Compounds at least one sterile drug. 2. Compounds before receiving a prescription. 3. Ships (sells) those drugs interstate.
In order to protect the public, the definition of compounding manufacturers should be broader, such as any entity that meets either the 2nd or 3rd criteria. Sterile drugs are not the only high-risk drugs made by compounders. Incorrect dosage for non-sterile cancer or other life-safe-giving drugs can be just as deadly, and are almost impossible to detect since drugs for seriously ill patients are not always effective. Therefore, when a cancer patient or heart patient dies after taking a compounded medication, it is unlikely that anyone will question the medication, and would instead assume that the drug just didn’t work on that patient.
In addition, a compounded antimicrobial drug that is not as potent as it should be will be ineffective and also add to our growing antibiotics resistance problem. By making the definition of manufacturing compounders too narrow, we are setting the stage for future public health disasters.
To protect patients across the country, we strongly believe that compounders who sell across state lines or sell “in anticipation” of prescriptions should be regulated as compounding manufacturers. This protection is especially essential when compounders sell drugs with the potential to save lives, where defective drugs could result in death or serious injury.
Traditional Compounder (page 3)
The phrase “compounds a drug in limited quantities” needs to be defined. What does “limited quantities” mean? A dozen, one hundred, or more?
Drugs That May Not Be Compounded (page 6)
The Secretary needs more flexibility to amend the list as needed. The bill should specify that the Secretary has administrative authority to update the Do Not Compound List (drugs added or taken off the list) and should not have to seek regulatory authority from Congress whenever a change is needed.
Licensed Pharmacist Oversight (page 18)
What does the term “direct supervision over the operations of the compounding manufacturer” mean? If a compounding manufacturer produces products 24 hours a day, does that mean a licensed pharmacist will be there at all times, directly supervising? Or could a licensed pharmacist just set up the operations and rarely be present? We urge you to clarify this definition to ensure robust oversight.
Listing of Drugs (page 18)
We support the six-month look-back on drugs that are made by compounding manufacturers. This allows the FDA to scrutinize them for products that should not be compounded such as commercially available products.
Adverse Event Reporting and Maintenance of Records (page 19)
We support Adverse Event Reporting and Maintenance of Records for compounding manufacturers. However, to truly protect public health, traditional compounders should also be required to report adverse events in a timely manner and maintain records of all serious adverse drug events for 10 years.
Labeling of Drugs (page 20)
The goal of the labeling is to make sure health care professionals and patients know that the drug is a compounded product. We support the label stating: “This is a compounded drug.” However, the draft proposal adds “or a reasonable comparable alternative statement that identifies the drugs as a compounded drug.” That sentence opens the door for vaguely worded compounded drug labels, which may be misunderstood by patients and healthcare providers. The alternative statement should either be deleted from the final draft or changed to “a statement that uses language suitable for an 8th grade reading level that clearly identifies the drug as a compounded drug that has not been evaluated by the FDA for safety and effectiveness or compliance with manufacturing and sterility standards.” In addition, we support the proposed labeling “not for resale” on compounded drugs sold to health care entities (page 17).
Amount of Establishment Fee (page 22)
The establishment fee for compounding manufacturers is designed to cover inspection costs. How was the $15,000 fee ($5,000 for small firms) per drug establishment determined? Did the FDA suggest this amount? What is the average cost for the FDA to inspect manufacturing compounders? Will the FDA have sufficient resources to do their job?
Applications of Inspection Requirements to Compounding Manufacturers (page 32)
The FDA should have access to the records of compounding manufacturers and traditional compounders. If the FDA cannot review traditional compounders’ records, then it does not have the means to independently verify that the companies are actually traditional compounders. This lack of access creates a Catch-22. Unless the FDA can prove the pharmacy meets its compounding definition, it cannot exert oversight. But it cannot prove the definition without access to records.
This lack of access also will make it difficult for the FDA to respond to complaints it receives about pharmacies, particularly in states where oversight may be lax.
What if the company meets all criteria of a compounding manufacturer but has not registered with the FDA? At the very least, the FDA should have, upon the receipt of a complaint or evidence that the pharmacy is violating federal law, access to all records and the right to inspect.
Language Missing in the Proposed Draft
There is no mention of penalties for compounding manufacturers who fail to follow the new regulations. FDA should have the authority to issue substantial civil penalties to serve as a disincentive for any compounding manufacturers that fail to register and pay an establishment fee to the FDA, or that fail to report adverse events within 15 days, and fail to retain records for ten years. Those penalties must be stringent enough to discourage compounders from considering penalties part of the cost of doing business.
Other suggested revisions to the draft
The draft should make clear that states that wish to ban the sale of certain compounded pharmaceutical products will not be pre-empted from doing so.
The draft should also require a GAO study of the impact of the bill on the FDA’s ability to effectively oversee compounding pharmacies, and address problems swiftly to prevent patient harm.
The draft should require the FDA to warn the public and the compounding pharmacy’s customers of any violations that threaten public health within 24 hours of discovering such violations.
Thank you for the opportunity to comment on this important draft legislation. It is our goal to work with you to make the improvements necessary so that this bill will provide the protections from unsafe medical products that the American public expects and deserves.
American Medical Student Association
Annie Appleseed Project
Jacobs Institute of Women’s Health
National Consumers League
National Research Center for Women & Families
National Women’s Health Network
Center for Science and Democracy, Union of Concerned Scientists
For more information, contact Paul Brown at (202) 223-4000 or firstname.lastname@example.org