The recent ruling by the FDA permitting states to import prescription drugs from Canada may not have a positive impact on President Joe Biden’s reelection efforts or the financial situations of American citizens.

The drug importation plan approved by the FDA on Friday in Florida still has a long road ahead before Americans can see any potential savings on their prescription costs. It is uncertain if they will even see any savings at all.

Pharma companies and the Canadian government — longtime opponents of bulk drug importation — are unlikely to sanction the flow of prescription drugs over the border. Canada has adopted regulatory guardrails to ensure drugs can’t be exported if it would exacerbate domestic supply issues, and drugmakers have indicated they won’t allocate more product to Canada than is earmarked for the country.

Eric Miller, a trade consultant based in Washington, stated that the chances of this plan coming to fruition are very low. He also mentioned that the FDA is aware that pharmaceutical companies will not exceed the supply for the Canadian market.

Although the decision may allow Biden to highlight another success in addressing drug pricing during his campaign, experts in polling and political strategy believe that the reality of Americans not experiencing a decrease in drug prices before November will diminish the impact of the FDA’s ruling on the presidential election.

According to Jared Leopold, a strategist for the Democratic party, the impact of this is not currently taking place and voters will not witness its effects before the election.

The FDA’s decision raises five inquiries.

Can import programs from the government effectively decrease the cost of medication?

According to Erin Fox, a senior director at the University of Utah Health who specializes in pharmaceutical supply-chain, the approval of Florida’s plan by the FDA will not automatically result in savings for patients.

Fox stated that in their opinion, Florida is attempting to take credit for addressing high prices, but when their efforts fail, they can shift the blame onto others.

Before drugs can be imported, Florida must first address several challenges. These include obtaining FDA approval for a list of desired medicines, implementing a system to guarantee their safety and legitimacy, and modifying imported medications to comply with FDA-approved labeling.

According to Lowell Schiller, the chief legal and regulatory officer at Aetion and former principal associate commissioner for policy at the FDA, federal law requires that any drug proposed for importation under the plan must undergo a thorough review by the FDA. The specifics of this review process are yet to be determined.

In 2021, Canada revised its regulations to prohibit the sale of drugs intended for Canadian consumers, including medicines that can be imported in bulk by the U.S., for use in other countries if it could potentially lead to or worsen a shortage of drugs.

It is typically permitted for individuals to obtain prescriptions in Canada and bring them back to the U.S., even though it is technically against U.S. law. The FDA does allow for certain exceptions for bringing medications across the border.

According to Miller, pharmaceutical companies have stated that they will not offer additional protection for products intended for the smaller Canadian market. This leaves the country with limited flexibility in terms of exports.

Stacie Dusetzina, a professor of health policy at Vanderbilt University Medical Center, believes that this is not a feasible option for even one state, let alone multiple states or the entire U.S.

According to ex-FDA head Scott Gottlieb, the restrictions would effectively prevent the implementation of the Florida plan’s drug importation.

According to Gottlieb, the policy cannot be put into action due to Canada’s actions. He stated that no legitimate wholesaler is able to transport goods to the U.S., and the FDA’s regulations do not permit the importation of drugs from sources outside of the legitimate supply chain.

What is the response of Canada?

The Canadian government has consistently resisted attempts by the U.S. to import less expensive medications from Canada. Officials have stated that as a country with a population roughly one-tenth the size of the U.S., Canada cannot fulfill the demand for prescription drugs without jeopardizing its own supply.

The Health Minister of Canada, Mark Holland, stated that the country’s drug supply will be safeguarded for its residents through strict regulations.

He stated that Canadians can trust that our government will persist in taking any necessary actions to safeguard the drug supply within Canada.

Will other states do the same thing?

Several states, such as Colorado, Maine, New Hampshire, New Mexico, Texas, and Vermont, have enacted drug importation laws in the past few years. These states temporarily halted their implementation plans while they awaited the FDA’s decision on Florida’s request.

In 2018, Vermont became the first state to approve a law allowing drug importation. However, the FDA, during the Trump administration, set forth official guidelines for the program in 2020, leading to Vermont’s application being deemed incomplete. In 2022, New Hampshire’s application was rejected because it did not specify a Canadian wholesaler for drug supply.

However, the FDA’s announcement on Friday allows certain states to proceed with their proposed plans and potentially allows new states to join in as well.

“Some states are actively seeking ways to decrease the cost of prescription drugs for their residents. Florida has been a leader in this effort. We are eager to see what deals the state will make with Canada and what lessons other states can take away from this approval,” stated Hemi Tewarson, executive director of the National Academy for State Health Policy.

Colorado, which is the next furthest along in the implementation process after Florida, submitted its application to the FDA in December 2022 and has waited for more than a year for its approval. In
a report to lawmakers last month, Colorado health officials said they anticipated submitting an updated application to federal officials in early 2024.

Colorado Governor Jared Polis stated to POLITICO on Friday that the approval of Florida’s plan for importing prescription drugs is a positive development and urges the FDA to promptly approve Colorado’s application for importing from Canada. This will allow for more affordable access to medications.

The recent approval by the FDA has been praised by health authorities in Texas, where a law allowing drug importation was passed last summer. They also announced that the state intends to file its own request with federal officials in the coming weeks.

“Texas Health and Human Services Commission welcomes the FDA’s decision on the Florida program as we believe it will support our efforts to implement” the newly passed legislation, said Mike Parker, a commission spokesperson.

However, the path ahead for Florida is lengthy and challenging. The state must navigate the obstacles of implementing its program while facing ongoing resistance from Canadian authorities. This may cause other states to continue with their cautious approach of observing and waiting.

In 2021, the North Dakota legislature approved a proposal to assess the viability of creating a drug importation system. However, Mark Hardy, the executive director of the North Dakota Board of Pharmacy, believes that lawmakers will not be eager to proceed with a similar program following Friday’s announcement.

Hardy stated that the FDA’s stance and approval process may not always be the main concern when it comes to the pressure point. It is more important to create a meaningful program. As Florida progresses, it will provide insight into whether it is a viable option based on the views of Canadian authorities, or if other policy solutions should be considered.

What are the potential effects on politics?

The Biden administration is determined to demonstrate to voters that it is addressing their financial concerns, as the economy remains a key focus leading up to the 2024 election. However, experts in politics and polling believe that the FDA’s ruling will not significantly influence voters unless they personally experience a decrease in the cost of their prescription medications.

According to Patrick Murray, director of the Monmouth University Polling Institute, the announcement alone will not have a significant effect. The key considerations are how soon it can be put into action, whether individuals will truly experience its effects, and if it will be sufficient to counteract the current negative feelings. However, the answer to these questions is uncertain.

Leopold stated that Biden’s actions to permit Medicare to bargain for lower prescription drug prices and limit insulin costs are expected to have a greater influence on voters.

Leopold stated that both Biden and Trump, to a lesser extent, can take some credit for this. However, it does not alter the overall situation of prescription drugs, where Biden has a significant advantage in the battle.

How will this impact the pharmaceutical sector?

The choice marks another obstacle for the pharmaceutical sector, which has been opposing importation regulations for many years. This comes after the Biden administration’s ruling in December to exercise its “march-in” authority, where the government can grant licenses for patents of expensive drugs developed with public funds to other companies.

Industry executives say that the doubts surrounding the program’s feasibility may lessen its effect.

According to John Murphy, the Chief Policy Officer of the Biotechnology Innovation Organization, although the idea of importing goods may seem like an effective solution for addressing pricing issues, it is unlikely to result in significant savings for American consumers. In fact, it may even raise more safety concerns instead of cost savings when fully implemented.

Additionally, a policy expert who has collaborated with the FDA and pharmaceutical companies stated that while this decision may appear to be an initial setback for drug manufacturers, they often find ways to mitigate its impact or even turn it into a positive outcome.

The expert, who wishes to remain anonymous, stated that the industry would rather not have to handle this issue. However, the chances of the industry facing significant consequences from it are not very high.

A lobbyist, who speaks on behalf of big corporations and wishes to remain anonymous, shared the same sentiment, stating that there are no plans for late-night meetings regarding the policy and that they are ready to handle it.

The choice to implement this decision will likely lead drug companies to face additional legal challenges in their battle against high drug prices. Currently, the industry is already involved in nine lawsuits regarding the Inflation Reduction Act’s requirement for Medicare to negotiate prices for certain costly medications.

When questioned about the possibility of a lawsuit, PhRMA representative Nicole Longo stated that they will once again carefully evaluate all available choices before taking action.

According to Peter Maybarduk, the leader of Public Citizen’s access to medicines group, there has been a change in attitude, with even Republicans showing support for these policies. This suggests that the pharmaceutical industry’s power is diminishing.

“The Death Star remains a powerful weapon capable of mass destruction, yet it is now susceptible to defeat,” he stated. “Significant changes have occurred and it has required a considerable amount of planning and coordination, though there is still much progress to be made.”