"Ready for dinner"
Early notification procedures have helped prevent new medication shortages, but the number of ongoing drug shortages has not fallen because quality manufacturing problems persist, pharmacy and hospital sources said. A program devised by the generic drug industry to mitigate shortages has not taken shape because of a lack of manufacturers in the marketplace, but industry is working with FDA on an agency proposal to collect more information about manufacturing quality to prevent future drug shortages.
Early warnings about potential drug shortages — a procedure codified in last year’s FDA Safety and Innovation Act — has helped FDA prevent new shortages, sources said. The number of new shortages — 86 as of July 31 — is at its lowest level since 2006 and well below a 2011 high of 267 new shortages, according to data from the University of Utah, which tracks the shortages.
The number of active drug shortages, however, remains at high levels. As of the third quarter of this year, there were 302 ongoing shortages — slightly higher than the 282 shortages during the same time last year, according to the University of Utah.
“We are stuck,” said Erin Fox, manager of the drug information service at the University of Utah.
FDASIA provisions aimed at curbing drug shortages have helped prevent new shortages, but there are no provisions being implemented that are aimed at solving the current ones. A highly anticipated Government Accountability Office report mandated by FDASIA could help shed light on the causes of drug shortages and lead to more action, including around economic factors, sources said. FDA is also working on a strategic plan that could provide additional solutions.
Sources agree that manufacturing quality problems — combined with a dearth of companies making these products — are a major cause of the shortages. There are still severe shortages of electrolyte and nutrition products stemming from the temporary shutdown of a Luitpold Pharmaceuticals, Inc., facility in New York because of quality issues, according to Fox.
Fox said there is not much information coming out of FDA or the company about when the facility will be up and running again, and other manufacturers are unable to make up the difference. Hospitals are rationing vitamins or building their own supplements from components. FDA has imported products but they are not the same, which can be difficult for hospitals, she said.
“We will use it if we have to but it is a safety risk whenever you use a product you are not familiar with,” Fox said.
The Generic Pharmaceutical Association’s Accelerated Recovery Initiative has also failed to get off the ground. Under the program, generic manufacturers voluntarily share their production planning and release schedule for products on a shortage list with a third party, IMS Health. IMS Health then models the data and shares the information with FDA, which will work with the companies to determine what is necessary to provide a solution to a shortage.
ARI is in place but GPhA, FDA and IMS Health have not identified a drug that would fit the model and benefit from the program, said David Gaugh, GPhA’s senior vice president of sciences and regulatory affairs. For the program to work, there have to be three or more manufacturers capable of producing a drug in shortage, but that is not usually the case with a drug on the shortage list, he said. “If you just have one or two companies that can make that product, ARI is not going to help,” Gaugh said.
Gaugh said there are five companies that produce sterile injectible products — a class of drugs severely affected by shortages that ARI intended to focus on. However, because of quality issues, about 20 percent of normally available capacity is offline so other companies are unable to fill in when one company is not able to produce a drug.
“We didn’t anticipate that so many companies would be undergoing remediation at the same time,” Gaugh said. “(ARI) is happening right now. We just can’t find the product that fits that model.”
Gaugh said companies need to make repairs and upgrades to facilities so they can open their manufacturing lines back up and produce at levels they used to produce at — a process that takes time.
Separately, GPhA and other drug industry trade groups are working with FDA on a proposal to collect more information about manufacturing quality. The agency floated the idea as a way to stem drug shortages of sterile injectibles, although the proposal has been met with some resistance by stakeholders.
“What is expected out of it is a set of measurable quality metrics that industry as a whole and FDA all concur on and once that is agreed to those metrics can be implemented and all companies can be looking at implementing within facilities those same set of metrics,” Gaugh said.
One pharmacy source, however, questioned the proposal. The source said pharmacists and hospitals are not as focused on the idea of paying more for a high-quality product but are interested in exploring the idea of paying more for a guaranteed supply of a product.
Further, the source said the upcoming GAO report could help flesh out some of the economic causes of drug shortages and an FDA strategic plan could provide an opportunity for the agency to work with stakeholders on the issue. Most stakeholders and some in Congress are taking a “wait and see approach at this point,” the source said.
“I think that we’re at this point where it would be helpful to work with the agency and other stakeholders on this strategic plan and work out all of the different elements of drug shortages and how can we sort of make a better pharmaceutical supply system out of this,” the pharmacy source said.
Fox said while FDA can speed up inspections and other regulatory actions in a shortage situation, there is nothing in FDASIA that would help speed up the time it takes companies to make improvements. She said incentives could possibly aid companies in making upgrades, or push other companies to enter the market.
“It seems like we are getting much closer to understanding the causes of shortages, but whatever will help incentivize the factories to have high-quality and fix themselves is what is needed,” Fox said. However, she questioned if incentives would even help. “The problem is that we have these factories that are struggling and it’s going to take time for it to get fixed and I don’t know if there is anything they can do to speed that up.”
“What we really need is a new manufacturer to recognize the market need and get into the market for the entire country,” she added. — Nanci Bompey <em>(</em><em>email@example.com)