FDA wants to seize and destroy imported Rx drugs
The FDA wants to eliminate your ability to import safe and affordable prescription drugs. They have proposed new rules that would give them the right to seize and destroy imported medicine.
The proposed rules pertain to section 708 of the FDA Safety and Innovation Act (S. 3187). More about section 708. The rules would give government officials the authority to destroy an imported drug valued at $2,500 or less that is refused admission under the Federal Food, Drug, and Cosmetic Act. What are the grounds for destruction? If the drug “is or appears to be adulterated, misbranded, or unapproved.”
The language gives consumers the illusion that they can appeal the FDA’s decision. They claim the proposed rule would provide the owner or consignee of a refused drug with:
1) Written notice that FDA intends to destroy the drug
2) The opportunity to provide testimony to prevent said destruction
But the cards are stacked against consumers on this issue, as usual. We already know that the FDA considers prescriptions imported from Canadian and other international online pharmacies to be “misbranded” or “unapproved.” It is a mistake to assume that the general meaning of the terms “adulterated” or “misbranded” applies here, because the Prescription Drug Marketing Act of 1988 prohibits drug importation by anyone but drug manufacturers. The fact that personal importation falls outside the allowed parameters of the act means any drug not imported by a drug manufacturer can be considered an adulterated, misbranded or counterfeit drug.
This means personally imported drugs—no matter how legitimate their point of origin—will be targeted. We believe the purpose of this new regulation is to sever your lifeline to safe, affordable prescription medicines from licensed, registered pharmacies outside the U.S. And if taking away needed medications wasn’t harmful enough, the proposed language puts patients on the hook for the cost of storage and destruction of the drugs as well.
Putting an end to importation has been a goal of PhRMA (the drug lobby) and its allied front groups for more than a decade and a half, during which time their predatory pricing practices have made the U.S. into a safe haven for the highest prescription drug prices in the world. In the FDA’s own analysis of the proposed rules, they admit that the seizures will likely benefit pharmaceutical companies “through increases in sales, brand value, and investment in research and development if the destroyed drug is a counterfeit or an otherwise falsified version of an approved drug.” Last we heard the FDA is tasked with protecting consumers, not the pharmaceutical industry’s monopoly.
Big pharma doesn’t need help from the FDA. The pharmaceutical industry already enjoys outrageous profitability at the expense of the American public. Pharma already enjoys a number of questionable competitive advantages that help to boost their profits, including lengthy patent monopolies, direct-to-consumer advertising and the ability to pay off generic competition in order to preserve profits.
While we share the FDA’s purported goal of protecting the American public from counterfeit drugs and rogue pharmacies, section 708 is a flawed approach to guaranteeing the safety of prescription medicines. The FDA has been allowing personal importation for years. If they were truly concerned about safety, why not conduct random testing of imported drugs? This would be more beneficial than destroying shipments of life-saving medications.
The FDA describes the primary health benefit of the proposed rule as “the value of the illnesses and deaths avoided.” We need to draw the FDA’s attention back to the incredible value that importation provides. Over the years, the ability to import safe, affordable medicine has helped preserve the health and welfare of millions of Americans—not to mention their financial security. If this lifeline is cut off, illness and death are the sure results.
Now is the time to speak out about the proposed rules! We’re in the midst of a 60-day public comment period (ends on July 7, 2014). During this time, in addition to preparing a public comment, we will be asking our supporters to take action. Those of you with Senators who have been supportive of importation in the past will be hearing from us via email (be sure you’re signed up for our list). We’ll be asking you to send letters to your Senators asking them to use their influence to ensure the FDA doesn’t proceed with these unjust rules.