Earlier this month 33 members of Congress sent a letter to President Obama asking him to use executive authority to tackle the crisis of high drug prices in the U.S. The gist of the letter is that Congress is paralyzed (surprise surprise) to act. So, while we wait, and wait, and wait for Congress — the urgency of high drug prices calls for executive action.
One of the steps recommended is to expressly permit Americans to import lower cost medications for personal use. Well, Americans already do that and while its technically illegal, people aren’t prosecuted for doing so, and thus it’s generally permitted. But if it was expressly permitted it would remove the stigma of illegality, embolden many more consumers to import lower cost medication, deflate and defang the scare tactics of the pharmaceutical industry about importation and online pharmacies, and would instill more price competition into the U.S. market to bring down prices at local pharmacies.
A few questions. Don’t we need to pass a new law to “legalize” importation? Why do I choose to bold the phrase expressly permit? Would it be legal or expressly permitted? Maybe both?
Congress’ letter reminds me that the Secretary of Health and Human Services has the authority, now, to make it technically legal to import medication from Canada through the creation of rules for both commercial and personal importation (and more). To bring those new rules into effect, however, the Secretary must certify that new importation would “pose no additional risk to the public’s health and safety;” That’s a tall order! Even when a new drug is declared safe and effective, meaning it is now FDA-approved, it will pose new risks to the public health.
There’s more than meets the eye in the current law and here’s where it gets interesting. It allows the Secretary to create guidelines for enforcement discretion to permit importation by individuals “by regulation or on a case-by-case basis.” The law states that the Secretary can “exercise discretion to permit individuals to make such importations in circumstances in which…the importation is clearly for personal use…and the prescription drug or device imported does not appear to present an unreasonable risk to the individual.” And this permission is not limited to just Canada but to personal importation generally. [The law is Section 804 of the Food, Drug and Cosmetic Act; Title 21, U.S.C § 384.]. Under current practice, personal imports are generally permitted in that over 99% of international orders reach consumers. But implementing the personal import waivers in Section 804 as described above, by definition, grants express permission, which would be a game changer.
The letter also asks the president to implement provisions under the Bayh-Dole Act, often referred to as “March in Rights,” that would break monopolistic pricing on drugs that were developed, at least in part, by you, the taxpayer. In this case, the authority to make this happen is shared among the Secretary of Health and Human Services, the Director of the National Institutes of Health, and Congress (good luck with that), but such authorities are subject to debate. The Obama administration appears to have rejected this idea already but has been recently approached again. We’ll see…
In a third request, the letter calls on the administration to task the Federal Trade Commission with banning the anticompetitive practice of “pay-for-delay” in which a drug patent holder (drug company) colludes with a generic drug company to postpone launching a lower cost generic version of the patented (brand) drug. The members of Congress believe there is executive authority to do so and clearly FTC wants to ban pay-for-delay. Banning pay-for-delay is pro competition and consumer so let’s hope it can happen!
The letter was signed by Democrats only, most of whom appear to be members of the Congressional Progressive Caucus. Maybe they are hopeful that President Obama in his last few months will rise to the occasion to use his executive authorities as they request. If not, hopefully the next president will. In the meantime, through RxRights.org, tell the president that you want action!
And as I wrap up the blog post for this week, a Google Alert appears in my email bringing to my attention a new Harris Poll showing that Americans Are Sick of Soaring Drug Prices. You think?Tagged with: bayh-dole, Congressional progressive caucus, march in rights, pay for delay