Ohio State College of Pharmacy Professor Mirtallo Advises FDA at Workshop on Drug Shortages

Daniel Helfand
Jay Mirtallo
11/18/2013
Jay Mirtallo

The United States Food and Drug Administration (FDA) has turned to The Ohio State University College of Pharmacy professor Jay Mirtallo and others to help subdue a critical drug shortage in the United States.

According to the FDA, some 342,171 Americans who rely on an intravenous fat emulsion product as a source of calories have been plagued by shortages of the drug throughout the United States. Mirtallo recently presented at a workshop hosted by the FDA to provide valuable information on some of the steps needed to approve a foreign IVFE product to quell shortages.

IVFE products are sources of fat calories used as a component of parenteral nutrition.  Parenteral nutrition provides all essential nutrients to patients who cannot get enough fat in their diets, including those with gastrointestinal tract disorders, recent surgery side effects and more. There has only been one IVFE product on the market in the United States since the early 1980s, which has led to continuous shortages of the drug.

“There are currently eight other IVFE products available outside of the United States,” said Mirtallo. “What others and myself hoped to accomplish at this workshop was give the FDA all the information it needs to make an effective evaluation of the IVFE products available, so we can introduce another one into the U.S. market.”

Mirtallo’s presentation summarized appropriate safety methods for vetting potential IVFE products. Specifically, Mirtallo discussed how infusion rates, doses and particle sizes are factors that come into play when evaluating IVFE products.

“The FDA has a process when it comes to approving a new drug: It must be efficacious, and the benefits must outweigh the risks,” said Mirtallo. “I am very pleased with how the FDA is opening up and allowing us to help establish a specific process for evaluating IVFE products that is congruous with their approval process.”

The workshop was attended by FDA officials, drug manufacturers, scientists researching fat metabolism, physicians, pharmacists and was also open to the general public. Patient advocates also attended the meeting, as Mirtallo noted an IVFE-dependent patient’s father came to share his thoughts on the matter.

IVFE products are not used by any specific age group, as patients from 1-85 years old use these drugs. Making sure there are enough IVFE products to satisfy demand without introducing ineffective or harmful products into the U.S. market is Mirtallo’s objective moving forward.

“IVFE shortages in the United States have been a continuous problem, and it’s not getting any better,” said Mirtallo. “My goal is that others and myself can work with the FDA to help approve a new product to make up for the shortages that have affected patients for a long time.”