There is a crisis of high drug prices. Skyrocketing drug costs plague this country, such that one in four Americans do not take their medication as prescribed, which causes avoidable illness or death. The international discrepancies are astounding: Prices on the top 60 brand-name drugs in the U.S. are on average 395 percent higher than in other high-income countries. So is it any wonder why, for decades, millions of Americans have chosen to import prescription drugs for themselves and their families?
Fortunately, with the Inflation Reduction Act, Congress finally passed legislation to help lower drug prices. The act will allow Medicare to negotiate some drug prices for the first time, curtail egregious price increases and cap out-of-pocket spending for Americans in Medicare at $2,000 per year.
These are great steps in the right direction, but they will not end the crisis. The new law tackles drug prices in Medicare, not for the uninsured and underinsured Americans in the private insurance market. They will remain vulnerable to high prices. In fact, it might get worse for them. The laws of economics, not to mention Big Pharma’s greed, will push manufacturers to raise drug prices outside of Medicare.
Americans will still need the lifeline of importing prescription drugs. Unfortunately, this channel of access is covertly under attack. Stuffed into the Senate Health, Education, Labor and Pensions Committee’s version of the Food and Drug Administration’s user fee bill — called the FDA Safety and Landmark Advancements (FDASLA) Act, Section 906 would remove protections for Americans who import prescription drugs for their own use.
The covert aspect of the legislation is that it appears to support importation from Canada. Indeed, Section 906 would codify a federal rule permitting states to sponsor Canadian wholesale drug importation programs. It was billed as a bipartisan compromise between Chair Patty Murray (D-Wash.) and Ranking Member Richard Burr (R-N.C.), both historical foes of importation, to help to facilitate importation from Canada.
The problem is that the federal importation rule is already painfully limited and codifying it would unnecessarily lock in those limitations. According to the National Academy for State Health Policy, the leading policy advocate for state-based drug importation, Section 906 would “potentially [give] states less flexibility” and “includes provisions that may delay state implementation or impact long-term sustainability.”
But it’s much worse than that. Section 906 could undermine the current access to personal importation that Americans rely on. One such American is the parent of Sen. Tim Kaine (D-Va.). During a meeting of the HELP committee to discuss Section 906, Kaine volunteered that his “father brings his glaucoma medication in from Canada— and has for years,” mentioning that “he’s a ‘lawbreaker’ but he saves a lot of money by doing it. And there’s a whole lot of people just like him.” He’s right. Approximately 2.3 million people in America import prescription medicine each year.
Kaine referring to his dad as a “lawbreaker” was somewhat exaggerated Technically, under most circumstances, drug importation is highly restricted under federal law. I write “technically” because over 20 million people have imported medicine and, while the FDA infrequently takes their medicine away, individual patients are neither charged nor prosecuted.
Many people believe that Americans are currently permitted to import prescription drugs through the FDA’s Personal Importation Policy, allowing patients to obtain treatments that are unavailable in the United States. Although true, few understand that the statutory basis for that policy is much broader. A subsection of federal law, (j)(1) of Section 804 of the Food, Drug and Cosmetic Act, allows and encourages the FDA to permit personal importation. It states that “the secretary” (of Health and Human Services) “should” use enforcement discretion to “permit individuals” to import prescription drugs for their own use that do not “present an unreasonable risk.” It’s a clear declaration of congressional support for personal importation by Americans who cannot afford prescription drugs.
Section 906 would eliminate the essential protections for personal importation in (j)(1). It would also take away the secretary’s authority to grant waivers under (j)(2) “by regulation or on a case-by-case basis” to individuals seeking to import prescription drugs. Finally, Section 804 (j)(3) states, “In particular, the secretary shall by regulation grant individuals a waiver to permit individuals to import into the United States a prescription drug” from a licensed Canadian pharmacy registered with the secretary. (Emphasis added). In other words, these regulations should be drafted already under current law.
Instead of “shall” or even “should,” Section 906 states, “The secretary may, by regulation, permit the importation of a prescription drug, or class of prescription drugs, for personal use…” (Emphasis added). That means the FDA would not be required to allow personal importation from Canada. Yet, Murray and Burr gave false assurance to Kaine that his dad would lawfully get his medication from Canada under the proposed legislation.
Adding insult to injury, Murray led the committee to table another amendment proposed by Sen. Bernie Sanders (I-Vt.) that would have genuinely expanded access to safe drug importation, not just from Canada but the United Kingdom as well.
The industry often decries importation as a gateway for counterfeit drugs that exacerbates the opioid crisis, with special vitriol for “rogue” online pharmacies. These are long-used scare tactics. They are less vocal about the fact that lower drug prices mean lower profits. Yet peer-reviewed research supports that, while there are dangerous foreign pharmacy websites, safe international online pharmacies require valid prescriptions and process orders filled by licensed pharmacies that sell genuine and safe medicine: and don’t sell opioids at all. (I would know because our company PharmacyChecker has verified the safety credentials of online pharmacies for almost 20 years).
Ironically, most of the prescription drugs we buy at U.S. pharmacies are already imported. The problem is that only pharmaceutical companies can import them for commercial distribution, which is a form of trade protectionism. Instead, we should regulate trade in pharmaceuticals with high-income countries so that Americans can more fully and lawfully benefit from lower drug prices in those countries.
Having finally passed legislation to lower drug prices in Medicare, we should not weaken current protections for other Americans who cannot afford prescription drugs and choose to personally import them. FDASLA has not come to a vote in the Senate and is not too popular in the House. Congress must ensure that the final bill strikes or amends Section 906 to prevent a step backward in the battle to make sure Americans can afford prescription drugs.
Gabriel Levitt is president and co-founder of PharmacyChecker.com, a company that verifies online pharmacies and compares prescription drug prices, and the founder of Prescription Justice, a non-profit organization dedicated to lowering drug prices in America.