Regulatory Focus™ > News Articles > Shortages Ongoing and Import Approach in Legal Jeopardy, FDA Turns to Expedited Approvals

Shortages Ongoing and Import Approach in Legal Jeopardy, FDA Turns to Expedited Approvals

Posted 07 October 2013 | By Alexander Gaffney, RAC

Despite the US Food and Drug Administration's (FDA) ongoing efforts, the problem of drug shortages is persisting with a stubborn tenacity, particularly in several high-need areas. But with its existing method of alleviating drug shortages in legal jeopardy, FDA now seems to be adopting a more permanent tactic to confronting some shortages: full and expedited approvals.


Drug shortages emerged as a major issue in 2011 and 2012, with many generic sterile injectable drugs experiencing supply shortages. Investigations into the matter brought to light a number of reasons for the shortages, including:

FDA has taken a number of actions intended to mitigate the effects of drug shortages over the course of the last year. Among them:

  • asking manufacturers to notify FDA of any impending supply problems or disruptions
  • working one-on-one with manufacturers experiencing problems to ensure production continuity
  • approving novel manufacturing agreements for some facilities to allow them to release some products for further processing or quality checks-a significant deviation from the usual quality-by-design parameters of current good manufacturing practices (CGMP)

Imports a Legal Casualty

But one of FDA's most favored ways of resolving drug shortages has been put into legal jeopardy. FDA has long used a tactic known as enforcement discretion, which refers to its well-established legal authority to decide which activities it will-and will not-take legal action against. In the case of drug shortages, this meant allowing certain drug products into the country without first putting them through a full and formal approvals process.

The tactic was notably used in 2012 to allow the import of Sun Pharma's Lipodox, a drug similar to Doxil (roxirubicin), which has been experiencing chronic shortages thanks to manufacturing difficulties at Ohio-based Ben Venue's Laboratories. The laboratory announced last week that it would close, likely exacerbating ongoing challenges.

In another instance in May 2013, FDA announced the import of an injectable nutrition drug known as total parenteral nutrition-an IV solution containing several drugs used to treat infants born prematurely and suffering from nutritional deficiencies.

But FDA has seen a significant setback thanks to the use of enforcement discretion to allow the import of another class of products, one not intended to heal patients but to kill criminals. Opponents of the death penalty have taken tactics in recent years meant to stifle the availability of drugs legally permissible in the lethal injection process. As a result, nearly all of the drugs are only available from outside the US.

FDA had taken to allowing the drugs into the country by way of its enforcement discretion, and advocates sued to halt the practice. In a series of two legal decisions, courts have ruled against FDA. The first decision, passed down by Judge Richard Leon, called FDA's actions "utterly disappointing," and said the authority had been improperly used. States urged FDA to appeal the decision, which it later did.

But in July 2013, FDA lost that appeal in the case of Cook v. FDA, with the judge specifically rejecting FDA's arguments that it needed the authority to protect against drug shortage shocks. It remains unclear if FDA has stopped its current use of the practice, of if it is appealing that decision.

Select Approvals

So if FDA seemingly can't import products to ease shortages, but the shortages still exist, what can it do?

Approve the drugs it would have allowed to be imported.

While it can't do so in every case (notably, those drugs still under patent or marketing exclusivity protections), many of the drugs in short supply are older generic drugs whose patents have long since expired, opening the chance for new competitors to come onto the market.

In February 2013, FDA formally approved Sun Pharma's Lipodox, allowing it to be imported into and sold in the US.

And now the agency has taken a similar tactic in the case of Clinolipid, a lipid injectable emulsion product intended for use in adult patients.

The 4 October 2013 announcement notes the drug has been in short supply, and that regulators had granted its sponsor, Baxter Healthcare Corporation, an expedited review process in order to help resolve the shortage.

"Today's approval of Clinolipid will help in the effort to resolve this shortage so that patients have access to these parenteral nutrition products," FDA said in a statement. The drug is notably not intended for use in preterm infants, FDA said. Its safety and effectiveness in other pediatric patients is unknown.

It remains to be seen if the cases of Sun Pharma and Baxter mark the start of a more regular trend of approvals, or simply a set of limited cases intended to solve especially pernicious shortage cases.

FDA Approval Notice for Clinolipid

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