US FDA pledges to work with drug makers on shortages
This article was originally published in SRA
The US Food and Drug Administration has said it is willing to work with drug makers to do what it takes to prevent medicines shortages or quickly resolve an issue, expediting its regulatory processes, if needed, to fix a problem.
The number of drug shortages in the US has dropped in the past two years – attributed largely to a law enacted in 2012 that imposed new notification requirements on biopharmaceutical makers – but there are still critical medicines for which there are shortfalls. "We know the problem isn't over," Captain Valerie Jensen, an officer in the US Public Health Service and the associate director of the FDA's Drug Shortage Program, told reporters during a 3 February media briefing.
Under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, drug manufacturers must report upcoming shortages to the FDA six months in advance or as soon as is practicable1,2. The FDA defines a drug shortage as a period of time when the demand or projected demand for a medically necessary medicine in the US exceeds its supply.
Those notifications have helped prevent "large numbers of shortages" from occurring over the past few years or lessen the impact if a shortfall cannot be prevented, Captain Jensen said. In 2011, there were 251 new shortages of medicines documented by the FDA. That number fell to 117 in 2012. Then in 2013, the amount of newly reported shortages dropped dramatically – plummeting to 44, which also was the same number reported last year, Captain Jensen said.
The FDA currently is overdue in submitting a FDASIA-required annual report on drug shortages for last year to Congress; this was due on 31 December 2014. "We are working to get it out as quickly as possible," an agency spokesman told Scrip Regulatory Affairs.
Intravenous saline solution
One vital product that continues to remain in short supply is intravenous saline solution. The shortage is especially problematic for hospitals, as the product is given to almost all inpatients.
The current shortage of IV saline started at the end of 2013, and it quickly became a severe problem, Captain Jensen said. Unlike many of the drug shortages issues, which are generally caused by quality or manufacturing problems, the deficit in IV saline was due to an increase in demand. "The companies just suddenly were not able to meet demand and got into a situation where even though they were at full capacity and producing 24/7 and getting as much product out as possible, it wasn't meeting demand,” Captain Jensen said.
To alleviate some of the pressure, the FDA permitted three manufacturers to import their IV saline into the US.
This not the first time the FDA has permitted an unapproved source to help fill the vacant orders for drugs in short supply. Over the past five years, the agency has allowed several unapproved drugs to cross the US boarder for patients in critical need, including methotrexate, propofol, foscarnet, ethiodol, thiotepa, norepinephrine, levoleucovoril and leucovorin, among others.
The FDA can use its "regulatory discretion" for a foreign version of a product to be imported on a limited basis until US needs can met by an approved version of the drug, Captain Jensen said. Bringing in the non-US approved saline on what the FDA is hoping is a temporary basis has clearly helped the situation, but Captain Jensen said "We don't feel we are out of the woods yet because we are still importing, still bringing in those overseas products."
"Until we have US manufacturers meeting all demand, we still consider it a shortage," Captain Jensen said, noting that US-approved manufacturers were doing everything they could possibly do at this time. "What we really need to get this situation completely resolved is… extra capacity," Captain Jensen said. "It's something we are encouraging the manufacturers to do, and of course, we will expedite anything related to that."
Captain Jensen said she could not comment on any particular applications that are under review related to the saline shortage, but said anything related to increasing capacity, the FDA is working to expedite it. "Companies are willing to work on this," Captain Jensen said. "So that's good news."
The sooner the better
The FDA is encouraging drug makers to notify the agency as soon as the companies perceive there may be a problem. "We are really trying to get companies to let us know as early as possible," Captain Jensen said. "Even if they foresee a problem down the road… that's the time we'd want to be talking so we can get people involved early on. Waiting until it's a problem is something we really don't want manufacturers to do. We'd rather know early on."
The FDA can bring in the experts in chemistry, microbiology or another discipline to help solve the problem as quickly as possible before it becomes a broader issue.
Captain Jensen noted that some drug makers have put off contacting the FDA about a potential problem out of fear the agency would quickly post a shortage notice on its website. But that is not the case." We are not going to post before there is a shortage," Captain Jensen said. Doing so, she acknowledged, could lead to increased purchasing or even hoarding – worsening the shortage situation.
"Our hope is we would be able to work with manufacturers to prevent, and if we can do that, we would never need to post the shortage. So we are letting manufacturers know that just because they notify us, that doesn't mean we will immediately post it. We will work with them on the timing regarding when that's appropriate."
Confusion over ASHP notices
Captain Jensen also said that the FDA had been working to clear up confusion over the differences in the types of notices the agency posts alerting about a drug shortage versus those the American Society of Health-System Pharmacists posts on its site. The FDA and the ASHP share the mission of reporting drug shortages – communicating daily and linking their websites together – but there are some key differences, she said.
The ASHP is looking more at pharmacy level and how a supply disruption would impact a pharmacy, while the FDA would be looking at national picture – the total supply from all of the manufacturers, their production, inventory and whether that supply is able to meet demands.
"So if one manufacturer is out of the market, but the rest of the manufacturers are meeting the shortfall and they are able to meet the shortfalls in the US, we wouldn't consider that a shortage. We wouldn't be posting that," Captain Jensen explained. "But ASHP most likely would because they need to let pharmacists know who to order from. They need to let them know this manufacturer is out of the product, however these others have the product available."
The FDA has posted a table on its website to help biopharmaceutical makers understand the differences in the notices posted on the agency and ASHP websites3.
To help healthcare providers and industry, the FDA is developing an app intended for use on a smart phone that provides a mobile version of the agency's drug shortages webpage, which is expected to soon be available, an FDA spokesman said.
References
- US FDA pursues new drug shortages actions, 5 November 2013, Scrip Regulatory Affairs,
- All too easy: Obama signs US FDA user fee bill without fanfare, Scrip Regulatory Affairs, 10 July 2012
- Contrasting the FDA (CDER) and ASHP Drug Shortage Websites: What are the differences?, http://www.ashp.org/DocLibrary/Policy/DrugShortages/FDA-versus-ASHP.pdf