A rise in shortages of key drugs is reaching crisis level for many patients nationwide as demand outpaces supply. Legislation has been introduced in Congress to address the issue, but questions remain as to whether the bill would address the real drivers of shortages.
Cancer, Behavior Drugs Hardest Hit
The American Society of Health-System Pharmacists (ASHP) lists more than 200 drugs on its current drug shortages bulletin; the list of resolved drug shortages is only about half that number. According to Joseph Hill, ASHP director of federal legislative affairs, shortages of methotrexate, a curative cancer drug, represent just one example of how lack of drug supply can affect a population.
“On the drug side, the real problem area we’re seeing is the cancer drugs,” Hill said. “There are also some pain medications, anesthetics, on the shortage list. That’s problematic because if someone needs a surgical procedure, that might have to be delayed. On the nutrition side, intravenous feeding, used for neonatal care or elderly folks who may not be able to eat or drink on their own. You run the risk of care being rationed, people being turned away from care.”
Behavioral modification drugs have also recently topped shortage lists, according to Kat Massetti, a pharmacist in Virginia.
“One shortage that has really created issues for people is the Adderall shortage, because it’s so tightly controlled,” said Massetti. “With other drug shortages, pharmacists have the leeway to substitute different strengths. If a patient is prescribed Levaquin 500 and we have Levaquin 250, we can just give them two pills without contacting the doctor. The problem with Adderall is that pharmacists are hesitant to substitute the strengths without contacting the doctor first since it’s controlled.
“We hardly ever know that a shortage is coming, and we’ll only notice it when we can’t order the product any more from our warehouse or distribution center,” Massetti added.
FDA Wants Early Notification
The reasons for drug shortages vary. On the manufacturing side, problems with product quality that result in halts or recalls, product discontinuations, and lack of availability of the active ingredients can all result in shortages. Hill also notes companies sometimes alter production goals to meet a shortage of another drug, halting or slowing production to focus on that drug. He also said quality problems arise from a lack of Food and Drug Administration (FDA) resources to expedite approval of supplemental new drug applications and conduct foreign inspections.
The Drug Shortage Prevention Act, a bill authored by Rep. John Carney (D-DE), would attempt to address these issues by expediting the FDA’s review of certain key drugs. The bill would set up a supply chain communication infrastructure by requiring drugmakers to inform the FDA when a shortage of a key drug was impending. According to an FDA spokesperson, the agency wants more “effective communication and early notification from manufacturers” when shortages are likely to arise so the FDA can “work with manufacturers to take early action to prevent or alleviate shortages.”
The ASHP agrees an improved early warning system at the FDA may help counter drug shortages to some extent. In 2011, early notification enabled the FDA to prevent 195 shortages, including 86 drugs produced by one company, according to Hill. Carney’s legislation would establish a national critical drug list and expedite FDA’s assessment of drugs in a shortage situation.
“We don’t have any complete solutions to this, and unfortunately, one many not exist,” Hill said. “We think an early warning system may help the FDA avoid drug shortages, if a manufacturer tells the FDA as soon as a company has to shut down its product, … when they’re able to know about those shortages up front. When FDA collects this information, they report to the public on actual drug shortages. Congressman Carney wants the FDA to also report the reason for the shortage, the duration of the shortage—all information that would be useful to clinicians.”
Government vs. Markets
Hill argues the government’s interventions need to be stronger.
“[Solutions are] not happening faster because right now, even in the cases where it’s required, the FDA has no enforcement mechanisms,” Hill said. “The bills would impose civil monitoring on companies.”
But according to Greg Conko, a senior fellow at the Competitive Enterprise Institute, more mandates on companies to notify the FDA would be of little help.
“To some extent, these measures may help, but the FDA has taken some modest steps on its own to address some of the most problematic shortages. And nothing in the legislation is likely to change the fundamental nature of how the agency operates. Nor would any of the bills address the fundamental underlying economic considerations that are the primary cause of the shortages,” Conko said.
Conko says delays in the FDA’s approval process and overly strict regulation of drug manufacturing facilities are the primary culprits for drug shortages.
“Drug shortages are a real problem. But the way to alleviate them is not to eliminate the market signals that incentivize adequate production,” said Conko. “In the end, we would be better off if Congress did nothing at all. Better still, though, would be for Congress to lift the rules that have contributed to the shortages in the first place.”
Ashley Bateman ([email protected]) writes from Williamsburg, Virginia.