During the 78 days that the Department of Health and Human Services (HHS) accepted public comment on the proposed rulemaking that would allow states to establish drug importation programs, individuals and organizations submitted 1,210 comments, and the Partnership for Safe Medicines read each of them. Below is a list of some of the key takeaways:
Probably one of the most important stakeholders – the Government of Canada – said they object to this proposed rulemaking.
If you could only read one comment, the Government of Canada submitted the most important one. We’re not sure whether foreign countries typically comment on regulatory processes in America, but the Canadians really weighed in here. Their statement said that “the proposed rule would not provide an effective solution to the problem of high drug prices in the U.S.” The Canadian government stated that any drug importation plan could exacerbate the shortages they have already been experiencing for years and that the country will take whatever steps are necessary to protect its drug supply for use by its citizens.
The Government of Canada also highlighted some cold, hard realities that proponents of drug importation seem to gloss over. For example, Canada imports 68% of its prescription drugs in finished form. The country’s drug market and manufacturing capability are too small to meet the needs of both countries. Canada’s population of 37 million is one-ninth the size of the U.S, and, as of 2017, Canada’s citizens accounted for 2% of global drug sales. U.S. citizens accounted for 44% of global drug sales.
We learned that proposed regulations need to assess their impact on Native American tribes as well as on consumer privacy. And this one didn’t.
A comment received from the Pharmaceutical Researchers and Manufacturers of America pointed out that the FDA failed to take into account how the proposed rulemaking might impact Native American tribes, which, given that the proposed legislation says that a tribe could sponsor a SIP, is a possibility. Additionally, the E-Government Act of 2002 requires that the federal government produce a similar report focusing on any impacts the proposed legislation would have on consumer privacy for the proposed program’s adverse event reporting requirements. The FDA has not produced this report
No Canadian commenters supported drug importation.
There wasn’t a single comment filed by a Canadian in favor of this policy. In fact, the organizations that filed comments included:
- The Canadian Pharmacists Association, who opposed the proposed rule “as it will negatively impact patient safety and outcomes on both sides of the border.”
- Innovative Medicines Canada (IMC), who warned that “Bulk importation under the proposed rule would result in drug shortages in Canada that would deprive Canadian patients of necessary medicines and strain international relations between Canada and the United States.” IMC also pointed out that Health Canada had a different and lower standard for drugs due to be exported outside of Canada, and that these products are specifically exempted from the approval process applied to prescription drugs meant for Canada’s population.
- The Best Medicines Coalition, a consortium of national and regional patient groups, which echoed many of the same ideas commented on by others from Canada: “bulk importation of medicines which are intended for Canadians is not viable and will put patients in Canada and the United States at risk.”
These comments reinforce what PSM has been saying about these ideas for a long time: the only drugs we are likely to get will be drugs smuggled through or out of Canada because the Canadians are not on board.
Even with all additional safeguards required, this proposed legislation breaks track-and-trace.
No matter what politicians say, Canada does not have a track-and-trace system, so any importation program will not be as safe and secure as drugs that have flowed through the FDA-regulated supply chain. Slapping a new National Drug Code onto a product just before it crosses into the country means a person can trace that drug back until just before it came into the country. The big three distributors in the U.S. are the same as they are in Canada – AmerisourceBergen, Cardinal Health, and McKesson. All three submitted comments expressing the same concerns and reservations – patient safety and the security of the drug supply chain. Additionally, all wholesalers in Canada have “do not export” clauses written into their contracts. As the American Pharmacists Association so aptly put it: “If this is the case, where will Foreign Sellers get drug products for import into the U.S. under a SIP?” The answer is: Not from the legitimate Canadian drug supply chain.
This potential for drug importation to weaken the security of the U.S.’s drug supply chain was one of the reasons the 2004 HHS Task Force on Drug Importation declared it infeasible: “Legalized importation of drugs in such a way that creates an opening in the “closed” system will likely result in some increase in risk, as the evidence shows that weaknesses in the oversight of drug regulation and the distribution system have been exploited. For example, doing so would increase the opportunity for counterfeit and other substandard drugs to enter and be dispersed into the U.S. drug distribution system.”
The entire proposed rule may be in violation of the savings clause of the 2003 law.
The Medicare Modernization Act of 2003 (MMA), the law that authorizes the Secretary of HHS to allow states to import prescription drugs from Canada, has two requirements. First, consumers must see significant savings, and second, the imported drugs must pose no additional risk to patients. A comment submitted by the Citizens Against Government Waste (CAGW) stated that “The proposed rule clearly demonstrates that few states or entities are going to be able to manage this complicated procedure and save their citizens money, but they will waste valuable tax dollars in trying. There is no estimate in the proposed regulation on how much the extra procedures will cost in comparison to the estimated savings. Any information provided is dubious because there are too many unknowns.” CAGW was not the only organization focused on the judicious spending of taxpayer’s money to submit a comment against the proposed rulemaking. Additional comments were received by Americans for Tax Reform, Center for Innovation and Free Enterprise, Taxpayers Protection Alliance, and the National Taxpayers Union.
Nobody who has any responsibility for preventing counterfeit medicines in the U.S. wants this either.
The National Association of Boards of Pharmacy (NABP), which represents all of the state boards of pharmacy, submitted a comment against the rulemaking. A review of the proposed rulemaking led NABP to note that the U.S. Food and Drug Administration (FDA) looks to be heavily relying on a state’s board of pharmacy to provide oversight of the State Importation Program (SIP), but it is their understanding that current state plans: “(1) have not been drafted with significant input from boards of pharmacy; and (2) once implemented, do not require meaningful involvement from boards of pharmacy in the oversight of the SIP. Failure to require meaningful board of pharmacy involvement could lead to negative outcomes ranging from poor safety records of SIPs to significant underestimates of costs, specifically with regard to operations and enforcement.”
The pool of potential drugs that could be imported is not as deep as you might think.
The Duke University Science Regulation Lab did a deep dive and submitted a lengthy comment on the proposed rulemaking. One of the many analyses they did was to examine which drugs would offer the most consumer savings. As they pointed out, 90% of prescriptions filled in the U.S. are filled with a generic, so importing those would offer no savings. When they looked at the top 20 grossing U.S. drugs from 2018, they found that only four would be suitable candidates for drug importation. They also found that none of the 20 most frequently prescribed drugs would a candidate for importation. Most of the top-grossing drugs are biologics and exempt from importation. The most frequently prescribed drugs were all generics, though three would be exempted from importation for various reasons.
Finally, a much-needed history lesson came from a former FDA Associate Commissioner.
Peter J. Pitts, the current President of the Center for Medicine in the Public Interest, submitted a comment reminding us all that other state-based importation experiments – iSaveRx in Illinois, Minnesota’s RxConnect, the city of Springfield in Massachusetts – failed to find the mythical savings they thought their programs would create. None of them are in operation anymore. During the 19 months that iSaveRx was operating, 3,689 Illinois residents used the program. RxConnect filled about 138 prescriptions each month before it ceased to exist. Springfield’s program suffered from low participation for years because American seniors found better prices due to the introduction of Medicare Part D.