At pediatric cancer clinics, doctors are scrambling to obtain cheap drugs that help cure their young patients.
At hospitals, newborns are dying because of zinc deficiency. The U.S. is seeing this problem, once found only in developing countries, because of shortages of injectable zinc.
And in ambulances, patients are screaming in pain because the crews don’t have sufficient painkillers.
Shortages of what the Food and Drug Administration deems “medically necessary” products — those that have a significant effect on public health — have recently spiked, their intensity and duration have worsened, and the impact on public health has been severe.
There are currently more than 100 medicines on the agency’s drug shortages list, and 35 new shortages were reported in 2017. Though the latter is much lower than in 2011, when 251 new shortages were reported, the number has been steadily increasing since 2015 when it was 26.
In July, the FDA formed a task force to examine drug shortages. The decades-old problem has many causes — from hurricanes disrupting work at plants where medicines are made, to lack of ingredients needed to make the drugs. Pharmaceutical companies’ business decisions and a supply chain from drugmaker to patient that lacks transparency are also to blame. Whether the FDA task force will recommend solutions that address Big Pharma’s power remains to be seen, but any ideas will likely need the approval of Congress and buy-in from drugmakers.
Impact of Increasingly Intense Drug Shortages
Frustration is growing in the health care community over lack of access to the most effective medicines.
In a May poll by the American College of Emergency Physicians (ACEP), nine of 10 doctors said their emergency departments had experienced shortages or absences of critical medicines in the previous month.
“Emergency physicians are concerned that our system cannot even meet daily demands, let alone during a medical surge for a natural or man-made disaster,” ACEP President Paul Kivela said at the time. “Congress must recognize that current shortages of essential emergency medications are a substantial threat to our nation’s preparedness and response capabilities.”
Yoram Unguru, a professor at Johns Hopkins Berman Institute of Bioethics, has also called for Congress to act.
“This may shock you to hear, but over the past 2.5 years, nearly two-thirds of these essential medicines for children with cancer have been or are currently in short supply in the U.S.,” he said at an FDA meeting in November. “Ultimately, what is needed is greater involvement by government. Congress must grant federal authorities the ability to ensure that patients in need have access to medications. Children with cancer should not have to continue to suffer because of inaction and a lack of will; they deserve better.”
Big Pharma’s Role in Drug Shortages
According to an FDA analysis, about two-thirds of drug shortages are the result of “failures in product or facility quality,” which can range from product contamination to leaky roofs. But private sector business decisions are also a factor.
A large percentage of drugs in short supply are produced by only one or two companies globally, yet the Federal Trade Commission is not required to consider FDA recommendations or the public health when evaluating corporate mergers. The Financial Times reported that such deals were booming this year with pharmaceutical companies spending the extra cash in hand thanks to the 2017 Republican tax bill that benefited big businesses. (Editor’s note: Tarbell is analyzing the impact of Big Pharma mergers for an article to be published in 2019.)
In July, FDA Commissioner Scott Gottlieb acknowledged that pharmaceutical industry mergers are one reason many drugs are in short supply and called upon companies to increase their capacity.
Even for drugs that the FDA deems “medically necessary,” when generic prices fall, manufacturers abandon production because the profits aren’t large enough. This is one reason that Unguru at Johns Hopkins has called for the U.S. agency to adopt the World Health Organization’s Essential Medicines List — a mandate that certain drugs must be available and affordable at all times.
In an interview with Tarbell, Unguru said that given the persistence of drug shortages, such a list would be only the start of a solution. The list, he said, “is relatively low-hanging fruit,” and more needs to be done.
“There has to be a partnership between the pharmaceutical manufacturers and government,” he said. “At this point, it is really a one-sided enterprise. The companies decide what they are going to produce and what they are going to charge.”
On Dec. 18, Sen. Elizabeth Warren (D-Mass.) and Rep. Jan Schakowsky (D-Ill.) introduced identical bills in the Senate and House, calling for the creation of an Affordable Drug Manufacturing Act, which would seek to reduce the high cost of some drugs while also addressing drug shortages. The legislation would establish an Office of Drug Manufacturing, which would make select generic drugs and offer them to consumers at affordable prices. “The solution here is not to replace markets, but to fix them,” Warren said. She noted that 40 percent of generic drugs are made by a single company, and most are manufactured by only one or two companies.
Among the bill’s provisions, the government would step in to manufacture a drug in short supply where competition is lacking and the drug is on WHO’s Essential Medicines List.
Unguru said it would be easier for government to partner with existing manufacturers, but there would have to be a way to keep them motivated. In other words, “they have to be able to make a profit,” he said.
When Gottlieb announced the formation of the FDA drug shortages task force — a group that includes senior officials from the FDA, the Centers for Medicare & Medicaid Services, the Department of Veterans Affairs, and the Department of Defense — he said that the it would also look at financial incentives to keep drugmakers producing. Unguru says this would have to be just one part of a bigger package.
Others believe government regulators need to consider public health when approving (or denying) mergers in the chemical and pharmaceutical industries, since they reduce the number of suppliers.
In 2017, researchers at the Brookings Institution proposed that streamlining the regulatory process would make it easier for drugmakers to launch during shortages. This new competition, according to Brookings, could help prevent price gouging. They found that amid drug shortages between 2007 and 2012, manufacturers of under-supplied drugs increased prices when “competitors were hit by manufacturing problems that lowered the quantities they could produce.”
Drug shortages have been on the FDA’s radar since at least 1999. Nevertheless, “shortages continue to pose a real challenge to public health,” especially when they involve cancer drugs, as well as basics such as intravenous saline and feeding solutions, according to the FDA.
“This affects everybody,” Unguru told Tarbell.