By Karla L. Palmer –
On December 5, 2012, Representatives Rosa DeLauro (D-CT) (the ranking member of the House committee responsible for FDA appropriations) and Nita Lowey (D-NY) (also on the House Appropriations Committee and a senior member of the Health and Human Services Subcommittee) introduced a bill to regulate prescription drug compounding in the wake of the fallout resulting from the New England Compounding Center matter. To date, the compounding incident is allegedly responsible for 500 illnesses aand at least 36 deaths. The proposed legislation, titled “Supporting Access to Formulated and Effective Compounded Drugs Act” ("SAFE Act") (H.R. 6638), would provide significantly greater federal oversight of compounding pharmacies. This latest legislation comes on the heels of the proposed VALID legislation (Verifying Authority and Legality in Drug Compounding), which bill was introduced by Congressman Markey on November 1, 2012 and blogged about here that also seeks to increase federal control of pharmaceutical compounding.
The SAFE bill provides as follows:
- Registration: The Secretary of Health and Human Services ("HHS"), in consultation with state regulators, health care providers, compounding pharmacies, and other stakeholders, would be required establish a process by which compounding pharmacies would register their facility with FDA through an electronic registration process. Subject to limited exceptions, every person who owns or operates a compounding pharmacy would be required to submit to a database specific information, including contact information for the pharmacy; the state of licensure; compounding methods used; and any additional information (that may include the quantity of products compounded) for the purpose of determining whether the facility is engaging in manufacturing, yet inappropriately registering as a compounding pharmacy. Exemptions would apply for compounding pharmacies that employ fewer than 20 full-time equivalents or perform traditional compounding of drug products that are used in a single state.
- Labeling: The proposed legislation seeks to ensure that patients know they are receiving a compounded drug by requiring that compounded drugs are appropriately labeled. The legislation would require the prescriber to inform an individual patient, including patients in a healthcare setting, that the individual is being prescribed a compounded drug, and to provide the patient information concerning safety, availability and the production of compounded drugs. The pharmacist must confirm that the patient received such information when he or she receives a compounded drug product. Furthermore, the product labeling must clearly indicate that the drug product is a “non-FDA approved compounded drug product,” and subject to other to-be-determined regulatory labeling requirements.
- Database: The legislation would require HHS to establish and maintain a database of information on compounding pharmacies that are licensed in more than one state to assist and inform oversight and inspection of compounding pharmacies by the FDA and state regulatory authorities. The database would include minimum standards for a compounding pharmacy license in each state and other information. The database would be accessible by both state and federal authorities and would permit the sharing of information.
- Production standards: The Secretary would also be required to set forth minimum production standards for compounded drug products, and to determine the particular products that would be required to meet the established minimum standards. The enhanced standards may include, but are not limited to, the intended route of administration for the drug product and whether the product is sterile or non-sterile. The Secretary may vary the minimum standards depending on type or intended use of the drug product.
- Training: The Secretary of HHS would also be required to conduct a series of training sessions for state agencies that regulate pharmacies and compounded drugs. The training would include information on to-be-established minimum product standards, sample inspection protocol and recordkeeping to facilitate inclusion of such information in the database described above.
The proposed legislation sets forth an 18-month deadline for the issuance of regulations addressing labeling and notification requirements. It would also establish an advisory committee comprised of patient or consumer representatives, state agencies, compounding pharmacies and health care providers, and “at least one member with expertise on clearly communicating information in such labeling of drugs.” (Safe Act at 9). The advisory committee must submit recommendations within 12 months after enactment of the Act. The proposed legislation similarly calls for establishment of a “database” advisory committee, comprised of representatives of consumers or patients, health care providers, compounding pharmacies, state agencies, and information technology experts, to consult on the development within 12 months of implementation of the proposed compounding pharmacy database. In addition, the Act would establish a permanent advisory committee on pharmacy compounding to consider issues “related to the safety and availability of compounded drug products.”
In addition to these various reporting requirements, the Act would require that, not later than six months after enactment, and each six month period (for 25 months thereafter), the Secretary of HHS must submit to Congress a report on the status of the implementation of the requirements of the Act and any amendments. The Secretary will also be required within 12 months to submit to Congress an additional report that would contain a review and effectiveness evaluation of standards used by organizations that provide accreditation to compounding pharmacies. Furthermore, not less than 18 months after enactment, the Secretary must submit to Congress a report that contains a review of models that states use to structure their oversight of compounding pharmacies, including how that structure may impact development and enforcement of regulations to ensure safety of compounded drug products.
And lastly, if the above does not impose enough federal reporting, the Act would require the Government Accountability Office to review the extent to which federal health care programs ensure (1) the extent to which compounded drug products are compounded in facilities that comply with the FDCA, (2) whether reimbursement rates for compounded drugs under such federal programs are appropriate, and (3) whether such programs encourage the use of compounded drugs in lieu of available, lawfully marketed drug products.
Finally, the proposed legislation would establish significant criminal penalties, including fine or imprisonment, for any person who knowingly and intentionally violates section 301(d) of the Federal Food, Drug, and Cosmetic Act with an intent to defraud or mislead or with conscious or reckless disregards of a risk of death or serious bodily injury. Lowey commented: “As recent events have made clear, it is critical to ensure compounding pharmacies are operating safely and the products consumers receive will improve – not jeopardize – their health. Federal oversight is critical to identify and correct potential problems and keep consumers safe.” The proposed legislation likely will not gain much momentum this lame duck session of Congress.