James D. Grant, M.D., M.B.A., FASA, was quoted on post-hurricane drug shortages. “We have to have some backup somewhere. We can't be dependent on one factory,” said Dr. Grant in reference to a plant in Puerto Rico that makes several widely used I.V. fluids that halted production due to Hurricane Maria. Read the full article below.
Drug shortages post-hurricane focus concerns on FDA disclosure policy
by Luis Sanchez | POLITICO | November 29, 2017
The damage Hurricanes Irma and Maria wrought on Puerto Rico's drug and medical device industry are casting light on what the FDA can and can't say about potential shortages — even in the absence of a devastating storm.
The FDA has a list of 90 "critically important" medical products it is monitoring to avoid potential supply disruptions, and nearly half of them are produced entirely or partially in Puerto Rico, where plants are still suffering from a lack of electricity and other logistical problems. But the agency won't name the products unless it decides an actual shortage has occurred. That policy discourages hoarding but can also play havoc with hospitals and other providers' planning.
And doctors and health systems, facing post-storm shortages, are voicing heightened concern. Drug shortages are not uncommon in the U.S., but they had been on the decline before the hurricanes, according to the FDA. For now, that progress has been reversed. The American Hospital Association recently sent the FDA a letter expressing concern that drug shortages are “quickly becoming a crisis” and urging the agency to approve new domestic suppliers in locations not prone to natural disasters.
But details about where drugs, biologics or devices are made and the quantities manufactured are generally considered proprietary commercial information, an FDA spokesperson said. No state or federal law requires manufacturers to publicly disclose such information, and the FDA is legally bound to keep the details under wraps.
The agency carefully weighs when to declare a shortage, fearing ensuing spikes in demand. But the providers complain that having to wait doesn’t leave them enough time to prepare contingencies. And getting the news on short notice could leave them relying on inferior alternative products.
James Grant, president of the American Society of Anesthesiologists and head of anesthesiology at Beaumont Hospital-Royal Oak in Michigan, said his hospital sometimes gets just two or three days’ notice about an upcoming shortage, forcing staff to scramble for new drug sources or create workarounds. Even when the hospital finds what it needs, it is in unusual quantities and likely at higher prices. In some instances, pharmacists are enlisted to split vials into syringes to ration a drug.
“As a clinician, I spend a lot of time just trying to figure out what we have and what we don’t have,” Grant said.
Hospitals often stay in contact with one another, so they can help each other out when there's a critical shortage. But they didn't anticipate the crisis that occurred when Hurricane Maria halted production at a Baxter plant in Puerto Rico that makes several widely used IV fluids used to administer drugs.
At Beaumont Hospital, that meant staff had to spend an extraordinary amount of time reformulating vital medications to match the available saline IV solutions, Grant said.
The FDA is working with Baxter to address the shortages and allowed the company to temporarily import solution from its plants in Ireland, Australia, Mexico and Canada as well as from other manufacturers in Germany and Spain.
Those steps, however, have met only 10 to 20 percent of what the medical industry needs, Grant said, raising questions about whether manufacturing should be more widely distributed.
“The problem was, why did we have such a tremendous number of our drugs that we need on a daily basis produced in one factory?” Grant asked. “We have to have some backup somewhere. We can’t be dependent on one factory.”
Six provider groups including the American Hospital Association and American Society of Clinical Oncology this month told a House Energy and Commerce subcommittee that the lack of transparency about drug manufacturing makes it more difficult to take steps to prevent shortages. The groups called on lawmakers to examine “how the pharmaceutical industry communicates information about what drugs are manufactured at which plants and where those plants are located.”
The groups also encourage redundancy in the market to ensure that more than one manufacturer is producing a critical product.
A spokesperson for Rep. Morgan Griffith (R-Va.), the vice chairman of the House Energy and Commerce Oversight Subcommittee, said that committee members are discussing drug shortages with the FDA and considering possible remedies.
The FDA lists the locations of manufacturing plants on its Drug Establishments Current Registration site. It provides an address and a business operation description but doesn’t say what's produced in the facilities.
“As health care professionals, we need to know where medications are made, what is made in pharmaceutical manufacturing firms and how much of a drug is made in that particular firm,” said Bev Holcombe, the clinical practice specialist for the American Society for Parenteral and Enteral Nutrition. “If we have that information, we can better prepare for any disruption in the supply of a medication. If there was another source, that source would perhaps have time to increase capacity and help mitigate or prevent a shortage.”
The lack of transparency about drug production makes it impossible to purchase the highest-quality medical products, according to Erin Fox, director of the drug information service at the University of Utah.
“FDA sees clear differences in the quality of the production facilities, but those are not disclosed to the public,” Fox said.
The FDA has not taken a position on requiring manufacturers to publicly disclose proprietary information. Confidential commercial information is exempt from disclosure under the Freedom of Information Act, and there are penalties for improper disclosure under the Trade Secrets Act, according to an FDA official. Only manufacturers can disclose confidential commercial information.
The American Society of Health-System Pharmacists, one of the provider groups pressing for change, has broached amending Title X of FDASIA — a law passed in 2012 that expanded the requirements for the FDA and manufacturers to address drug shortages — to require manufacturers to provide additional information like shortage duration and expected timelines, according to Christopher Topoleski, the group's director of federal legislative affairs.
Fox said requiring added transparency could create an incentive for manufacturers to produce higher-quality medicines.
“The medicines that we buy, there is no requirement to disclose the company that made a product. It is not like buying a shirt where you can see it was made in Indonesia or China,” Fox said. “With medicine, unless the company chooses to disclose, it is a complete secret.”
Topoleski said the current situation, exacerbated by Puerto Rico, begs a reassessment of whether too much is deemed proprietary. "We think that this lack of transparency puts the health care system at a significant disadvantage.”