Facing Dire Shortage of IV Saline, FDA Again Turns to Enforcement Discretion Approach

Posted 30 April 2014 | By Alexander Gaffney, RAC 

In the face of mounting concerns about a shortage of intravenous saline solutions, the US Food and Drug Administration (FDA) announced it is once again utilizing an uncommon regulatory mechanism to ease the shortage-a mechanism no longer on the strongest of legal footings.


Drug shortages have been an ongoing problem in the US since at least 2011, and have been blamed on a number of causes, including quality problems at manufacturing facilities, overly aggressive regulation and enforcement by FDA, low profit margins for drugs, and gray market pharmacies.

To confront these shortages, FDA has been employing a tactic known as "enforcement discretion," in which it permits drugs which haven't otherwise met its regulatory standards (such as approval) to enter the country. By FDA's own estimates, it uses enforcement discretion in about 5% of all drug shortage cases.

For example, in 2012, FDA used the tactic to allow for the import of a substitute for J&J's Doxil (doxorubicin) manufactured by Indian generic pharmaceutical company Sun Pharma known as Lipdox. That same year, FDA allowed Hospira to import methotrexate from one of its Canadian facilities to ease a shortage of the drug in the US. And in May 2013, FDA said it would also allow the import of total parenteral nutrition (TPN) drugs based on a shortage situation in the US.

In all cases, FDA indicated that while the drugs may not have been approved, it was confident that the imported drugs would be of the same (or similar enough) quality as US-approved variants of the drug.

Legal Troubles

But FDA's ability to exercise its enforcement discretion policy came under heavy fire in 2012 and 2013 thanks to its use in allowing the import of products used to execute some prisoners.

In February 2012, activists began the first of many challenges against FDA's authority to allow the import of sodium thiopental, which currently lacks approved status in the US. The only approved version of the drug, Abbott's Pentothal (#011679) has been discontinued, requiring it to be imported from abroad. As states have turned to imports to meet their supply demands, legal teams have sued both states and FDA, claiming the drug samples were "wrongfully diverted," and are thus in violation of import restrictions.

In March 2012, Judge Richard Leon - a regular thorn in the side of FDA - ruled against FDA's allowance of sodium thiopental imports, saying the agency "appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the executioner's needle."

As Focus noted at the time, the decision was notable for its ability to have wide-ranging effects on drug shortages. Because Leon essentially called into question the legality of its very use of enforcement discretion, the decision could impact the agency's ability to import unapproved analogues to drugs experiencing shortages.

Shortly thereafter FDA appealed that decision. But in July 2013, the DC Circuit Court of Appeals again ruled against the agency, saying that laws banning unapproved drugs from entering into the US were "unambiguous" and not subject to enforcement discretion.

The issue of drug shortages was also on the minds of justices when rendering their decision. Writing for the court, Judge Douglas Ginsburg wrote that FDA does not need enforcement discretion authority, and has "ways short of allowing importation of inadmissible drugs to counteract a drug shortage."

"The FDA may exercise enforcement discretion to allow the domestic distribution of a misbranded or unapproved new drug, as the Supreme Court recognized in Heckler v. Chaney, 470 U.S. at 837, and in some cases may invoke its express statutory authority to permit the importation of an unapproved new drug," he continued. "For example, the FDA may designate an unapproved foreign manufactured drug as an investigational new drug (IND), thereby allowing its lawful importation."

However, Ginsburg conceded that the revocation of authority would potentially deprive FDA of its authority to allow the import of unapproved drugs, but said that given the alternative options, "That is hardly an absurd result."

In the aftermath of the case, Focus noted that FDA seemed to be adopting other back-up approaches for solving drug shortages, such as expedited approvals.

New Shortages, Same Old Approach

But if it had appeared that the case of Cook v. FDAhad put the agency on uneven legal footing to use enforcement discretion to import drugs to ease shortages, the agency doesn't seem to be paying much mind.

In a 28 April 2014 announcement, the agency said that it would allow Baxter Healthcare Corp and Fresenius Kabi to temporarily distribute normal saline in the US in light of ongoing shortages of saline product.

FDA explicitly noted that its allowance of the import is being done under its "enforcement discretion" approach, and that it had already determined that Baxter's Spanish manufacturing facility met its regulatory requirements. It made no mention of any inspection of Fresenius' Norway facility, however.

FDA added: "While the shipments described above will help reduce current disruptions, they will not resolve the current shortage of 0.9% sodium chloride injection. Preventing drug shortages is a top priority for the FDA, and we are doing everything within our authority to improve access and alleviate this shortage."

In other words: Even if federal judges aren't sure importing drugs using enforcement discretion is always within the agency's authority, at least when it comes to addressing drug shortages, FDA still maintains that it is.

FDA Notice on Saline

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