Take Action to Protect Our Medicine Supply: Deadline December 20, 2019
If the rush to import medicines causes you concern for the safety of American patients, please join us by signing this letter that we will send to HHS Secretary Alex Azar and the FDA Commissioner as Congress returns from Holiday recess. It outlines some of the safety provisions in the 2003 Medicare Modernization Act that importation programs must obey. We unified in our concern that these safety provisions must be enforced.
To: HHS Secretary Alex Azar and the FDA Commissioner
From: The Partnership for Safe Medicines and other signatories below.
Re: Safety Considerations of Federal and State Importation Programs
Dear Secretary Azar and FDA Commissioner,
The Partnership for Safe Medicines (PSM) and other signatories below are concerned about the proposal to source medications from outside the FDA-regulated supply chain as envisioned by state legislation in Florida, Colorado, Vermont, Maine, and the recently proposed “HHS Safe Importation Action Plan” regulations that are currently being prepared by the Office of Management and Budget. We fear that this plan will create a two-tiered system of safety where safe medications are available to those that have financial means, and medicines subjected to less rigorous inspections and regulation are left for those without financial means.
As the primary agency with sufficient expertise in public health protection, the burden of solving the open questions about safety, testing, recalls, labeling, liability, economic feasibility, and other issues falls to FDA. Today we ask you to ensure that you disallow any program to go forward that is inconsistent with FDA’s and HHS’s mission to protect the public health.. Here are several areas of concern and our recommendations for the draft federal guidelines you are preparing.
We ask today that you ensure the following safety steps are part of any Administration importation plan. More detail on each safety measure is attached to this letter.
- Ensure a statistically valid testing regime for 99.999% confidence and reliability.
- Ensure labeling and Track-and-Trace requirements are met without shortcuts.
- Disallow programs that reduce safety or fail to reduce cost.
- Collect, review, and archive all required paperwork within the FDA for a transparent process.
- Increase law enforcement resources commensurate with increased risk.
The 2003 Medicare Modernization Act set in law a high threshold for allowing a foreign prescription drug importation program to be implemented. Violating any of the above requirements would make an importation program patently unsafe. The safety of Americans will depend on your strong interpretation of these guardrails.
The Partnership for Safe Medicines and other signatories below
Additional information about the role of the 2003 Medicare Modernization Act and the restrictions it puts on any importation program
Ensure a statistically valid testing regime for 99.999% confidence and reliability.
Previous importation programs, such as Maine’s failed 2013 program, saw substandard and counterfeit medicine come into Maine that were only revealed by lab testing. Minnesota and Illinois both ran importation programs without any integrity testing. The 2003 Medicare Modernization Act (MMA) and many state laws are clear that imported medicine must be tested, and that testing should be done in a statistically valid manner. Random sampling is insufficient to achieve this; the testing must be robust enough to ensure the statistical safety of imported products.
Ensure labeling and Track-and-Trace requirements are met without shortcuts.
Most states that have passed importation laws require that all products comply with state and federal requirements for Track-and-Trace as defined in the Drug Supply Chain Security Act (DSCSA) that currently is being implemented. The 2003 MMA also has requirements that medicines imported by wholesales and pharmacists comply with Section 505 of the Federal Food, Drug and Cosmetic Act (FDCA)—the statutory provision for FDA approval—Sections 501 and 502 of the FDCA—the statutory provisions regarding adulteration and misbranding—and “other applicable requirements of this Act.” The DSCSA is such a requirement. Advocates of importation have already suggested methods of complying with the DSCSA Track-and-Trace that would, in fact, not comply with the DSCSA. For example, it has been recommended that DSCSA compliance could be achieved by having a party that is not the original manufacturer add labels with manufacturer barcodes (i.e., “product identifiers”) at a later point in the supply chain. Such a proposal violates the DSCSA, which requires all transactions in the supply chain involve product with a “product identifier,” beginning with the original manufacturer.
Disallow programs that reduce safety or fail to reduce cost.
The 2003 MMA is clear that programs importing medicines from Canada must “pose no additional risk to the public’s health and safety” and must “result in a significant reduction in the cost of covered products to the American consumer.” There are many variations of programs that would save money for supply chain participants but not consumers. An analysis projecting the savings must be documented and regularly evaluated.
Additionally, ensuring patient safety costs money. We urge you to apply impartial expertise to applicants’ programs to ensure they truly meet these requirements.
Collecting, reviewing, and archiving all required paperwork within the FDA for a transparent process.
The 2003 MMA and state importation require a great deal of documentation pertaining to vendors and transactions to be recorded and kept. HHS should select an office within FDA as the department that receives this paperwork. This department must be responsible for reviewing the ongoing compliance, providing Congressional oversight, and ensuring that the process is transparent to the public and additional FTEs must be appropriated to staff it. Indeed, this is required under the 2003 MMA provides that HHS “shall maintain information and documentation submitted under [wholesale importation regulations] for such period of time as the Secretary determines to be necessary.”
Increase law enforcement resources commensurate with increased risk.
Importation will increase the burden on law enforcement at the federal, state, and local level. Regulatory systems only work if participants are held accountable. In Florida, in the early 2000s, we saw danger nationwide from an under-regulated secondary wholesale market. HHS should ensure that any importation program both accounts for increased resources being directed to law enforcement, or allocating additional resources from new sources to ensure public safety.
How Else Can I Help?
- Send a letter to your elected officials about the dangers of drug importation.
- Become a member of The Partnership for Safe Medicines (email us at email@example.com).
- Sign up for our weekly newsletter, to keep up to date on counterfeit drug news and share our stories with your members or community.
- Share our online resources to make sure your colleagues, friends and acquaintances understand the need to protect the U.S. drug supply.
- Contact our Executive Director, Shabbir Safdar, at firstname.lastname@example.org to discuss advocacy and education opportunities.
Congress and state legislatures across the country are considering proposals that could open our nation’s drug supply to unsafe and counterfeit drugs. It is crucial that Americans let our government know that we reject proposals that compromise the safety of U.S. patients. To learn more about why proposals to weaken the supply chain to import cheaper medicine from other countries don't work, see our Policymakers page.