Carney’s bipartisan bill aims to address drug shortages

U.S. Rep. John Carney is reaching across the aisle to help medicine reach the patients who need it. On Jan. 31, the Delaware Democrat introduced House Bill 3839, the Drug Shortage Prevention Act. Responding to the 230 drug shortages that occurred in 2011, the bill would aim to improve U.S. Food and Drug Administration communications and address drug shortages proactively.

“Since 2005, the number of drug shortages in the United States has quadrupled, and cancer patients have been disproportionately impacted by this troubling trend,” said Carney. “We must ensure that Americans have access to the critical drugs they need to stay healthy and fight back against deadly diseases.

“The Drug Shortage Prevention Act brings more efficiency to the manufacturing and distribution processes and requires the FDA to take action to prevent drug shortage problems before they begin impacting patients,” he added.

Cancer drugs, anesthesia drugs and nutrition medicines are often affected by these shortages, according to Carney’s Web site. Many of these drugs are difficult and time-consuming to create, so there are only one or two manufacturers in the market. Thus, when a manufacturing problem occurs, it can quickly cause a shortage.

There is currently no official system to address drug shortages. Sometimes doctors are not aware of a problem until the medicine doesn’t arrive on a delivery truck.

“This is not a partisan issue,” Carney told Congress. “Drug shortages affect all of us, and so I urge my colleagues to quickly pass this bipartisan legislation. When a family gets hit with a diagnosis like cancer, they have enough things to worry about. Running out of chemo drugs should not be one of those things.”

Carney is cosponsoring the bill with Rep. Larry Bucshon of Indiana, another first-term congressman. The Republican was a practicing physician in his home state.

The act would establish a list of critical drugs in the U.S., including information about the number and identity of manufacturers of such drugs.

That would lead to a National Critical Drug Shortage List, to be updated at least monthly. The public would receive notice regarding changes to the list. Manufacturers and distributors of the critical drug would also receive notice, as would those with a capacity to produce critical drugs or alternate therapies.

The Drug Shortage Prevention Act seeks to improve regulation and communication. Under this bill, any new regulatory concern about a critical drug identified by Food and Drug Administration personnel must be communicated within one day to the agency’s office for addressing critical drug shortages. Within five days, the manufacturer must be notified, as well.

Because there are sometimes incidents of distributors allegedly intentionally stockpiling or price-gouging medicines, those companies would receive no notice of shortages until the Attorney General determined the illegal practice had ended.

The act also calls for a feasibility study of a national contingency plan, such as creating or expanding federal stockpiles of critical drugs, in case of shortage.

H.B. 3839 also aims to address problems involved with government procedure. The public notifications must be published in language understandable to the everyday lay reader. Plus, the bill notes that this project will require additional staffing by the FDA.

After the bill was introduced, it went to the House Energy and Commerce Committee and the House Judiciary Committee for further study. Those committees, the House of Representatives, Senate and president must all approve the Drug Shortage Prevention Act before it becomes law.