Supply Shortages Persist; Delegation Seeks Answers & Solutions

While the shortage of drug products manufactured in Puerto Rico has eased a bit in recent weeks, hospitals are still reporting that they are low on IV bags, saline and emergency products. The shortages are so destabilizing that last week the entire Massachusetts Congressional delegation led by Senator Elizabeth Warren signed a letter to FDA Commissioner Scott Gottlieb, M.D., seeking a briefing on the issue.

When Hurricane Maria struck on September 20, 2017, manufacturing in Puerto Rico took a massive hit as power was lost to most of the island. Almost 10% of U.S. pharmaceutical expenditures are for more than 1,000 drug products manufactured in Puerto Rico, the delegation noted in its letter.

Since last September, after a series of miscues, recovery began in Puerto Rico and the FDA recently took a number of steps to mitigate the shortage, such as extending product expiration dates. But the challenges continue, especially around access to intravenous solutions. The delegation letter to the FDA Commissioner outlined the drastic measures Massachusetts hospitals are taking to alleviate the shortages; IVs are now being administered – at greater cost and staff time – by the “IV push” method, and hospitals are compounding solutions in-house.

“Hospitals are reporting shortfalls of potassium chloride, lorazepam, and anesthetics like lidocaine or bupivacaine,” wrote both of the commonwealth’s U.S. Senators along with all nine U.S. Representatives. “While our state’s hospitals continue to provide the highest-quality medical care to patients, addressing these shortages is costly and time-consuming.”

The letter cites reports it received from MHA President & CEO Steve Walsh, who traveled to D.C. last month to meet with the delegation on the supply shortages and other federal-state issues.

Walsh said of the letter, which asked for an FDA briefing by February 23, “Our delegation ‘gets’ healthcare. They understand the strong foundation that hospitals provide to the Massachusetts economy and to the health and well-being of its citizens. When that foundation is threatened – whether through supply shortages or attacks against Medicare funding or healthcare access – the delegation is incredibly responsive.”

A second, similar letter to the FDA’s Gottlieb was signed by 30 Senators and 63 Representatives. That letter called on the FDA to detail, among other items, the steps it is taking to prevent new shortages from Puerto Rico, and to ensure manufacturers are creating contingency strategies to avoid future shortfalls. Massachusetts Representatives Stephen Lynch, Bill Keating, Jim McGovern, Seth Moulton and Niki Tsongas signed that letter.