Senators Say FDA Import Regulation Would Harm Vulnerable Consumers

Posted 10 July 2014 | By

Senators Say FDA Import Regulation Would Harm Vulnerable Consumers

Four US senators are pressuring the US Food and Drug Administration (FDA) to walk back a rule proposed by the agency in May 2014 that would make it more difficult to import unapproved drugs into the US.


The proposed rule, Administrative Destruction of Certain Drugs Refused Admission to the United States, is meant to tweak the agency's pharmaceutical import provisions under Section 801(b) of the Federal Food, Drug and Cosmetic Act (FD&C Act).

Under the status quo, FDA is permitted to refuse to allow the import or entry of an unapproved drug into the US. However, the law typically requires that the agency either turn the drug away (refuse entry) or subject the product to administrative detention procedures if the product requires minimal further processing.

This detention provision allows for FDA to prevent a drug from entering US commerce, but also permits an individual or company to appeal FDA's decision and re-obtain their drugs.

The problem, as FDA has indicated, is that sometimes the "importer" isn't an established pharmaceutical company, but instead an individual or small company looking to illegally import drugs not approved in the US.

And under existing law, the same provisions that allow a company to re-obtain their drug products also allow individuals to do the same within 90 days.

For FDA, that process is akin to if the Customs and Border Patrol officials were required to return seized cocaine to drug traffickers. In fact, FDA said the current process is so broken that some drugs it has refused entry to and returned have actually been re-sent to the US in the same packaging and bearing the same sticker indication of prior FDA refusal.

New Proposal Comes Under Scrutiny

To counter this, FDA proposed a new rule which would allow it to seize and destroy drugs provided the drug product is valued at less than $2,500. FDA would still provide the owner of the drug with written notice of FDA's intent to destroy the drug and an opportunity to present testimony to FDA, but the key change would be that it would no longer be re-exported if it was refused entry.

But according to a letter sent this week to FDA Commissioner Margaret Hamburg, four US senators think the proposal will do more to hurt US consumers than to help them.

Sens. David Vitter, Charles Grassley, Dean Heller and Angus King wrote in the letter that they have "serious concerns" about the proposed rule, and are urging FDA to adopt "significant changes to the proposal," which they call "sweeping and arbitrary."

"This proposed regulation constitutes a potential health threat to hundreds of thousands of Americans who receive their affordable drugs from safe, licensed and legal pharmacies in Canada," the senators wrote, citing a study which indicated that as many as 50 million Americans avoided filling a prescription in 2012 due to the high costs of prescription medication.

"We request that the final regulation contain a requirement that patients be notified that their drugs could be destroyed at least six months in advance of their medication being denied to them," the senators proposed.

The senators also asked that FDA implement the rule in phases, focusing the majority of its efforts on narcotics and other controlled substances during an initial five-year period, and then other drugs in subsequent years.

"This would allow the FDA to continue to make closing dangerous rogue pharmacies a priority while allowing consumers who purchase affordable medications from Canada time to identify alternative sources," they wrote.

It is unclear how FDA would distinguish between drugs from Canadian pharmacies and those purporting to originate in Canada.

The Senators make no note of Section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which explicitly gave FDA the authority to destroy adulterated, misbranded or counterfeit drugs without the opportunity for export.


Letter to FDA


[DataConnection.HandleError]: Query: SELECT [CategoryID], [CategoryName], [Icon] FROM RAPS_News_Category WHERE (DisplayOnFrontEnd=1 AND CategoryID IN(,395)) ORDER BY CategoryName ASC Caused exception: Incorrect syntax near ','.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles