© 2025
Play Live Radio
Next Up:
0:00
0:00
0:00 0:00
Available On Air Stations

Cancer treatment drug shortages; can the government increase availability?

By Patrick Donges

http://stream.publicbroadcasting.net/production/mp3/wamc/local-wamc-982462.mp3

Pittsfield, MA – According to the U.S. Food and Drug Administration, drug shortages across the country are on the rise, including drugs used to combat cancer that have been established as necessary for certain courses of treatment.

Health providers say the reasons these drugs have become scarce are primarily economic; Dr. Richard Schilsky is chief of the section of Hematology and Oncology at the University of Chicago and the former president of the American Society of Clinical Oncology.

"Fundamentally it is an economic reason. There is a big problem with the generic drugs being inexpensive and there not being much profit margin associated with making those drugs."

"So, if there's a manufacturing problem or if there's a raw materials supply problem, there's also not a great deal of incentive for the generic manufacturers to try and resolve the problem as opposed to just refocusing on making other products."

While the FDA can't force companies to produce specific drugs, they could require advanced notification of pending shortages; Two different bills currently under consideration by Congress, Senate bill 296 and House bill 2245, both known as the "Preserving Access to Lifesaving Medications Act of 2011," would tighten the process of reporting and disclosing shortages.

Advocates say changing how shortages affect business could help raise awareness of the issue; Matthew Farber is director of provider economics and public policy at the Association of Community Cancer Centers, or ACCC.

"Currently when a shortage is occurring it's the providers' responsibility to report to the FDA that they can't get a hold of a drug. The primary focus of these bills is to shift that to the manufacturers; making it the manufacturers' responsibility to report when an impending shortage may be happening."

The House version of the bill goes a step further, calling for the establishment of daily civil penalties up to $10,000 for those companies that knowingly fail to report.

Both bills also call for a briefing by the Secretary of Health and Human Services one year after the new polices would be enacted, and the House bill would require a study be conducted by the U.S. Government Accountability Office to identify and report on any recommended additional policy steps.

While these policies might increase accountability and make businesses take a more active role in addressing the issue, Farber said more work will need to be done.
"Most people will tell you, and we agree that that in and of itself probably won't solve the problem, but it is helping to kind of shine a light on this issue."

"The question also that some people have been raising is, is a legislative route, the best way to try and fix this?" Some of these factors that impact shortages can't necessarily be regulated per-se."

Those factors include breaks in the supply chains of raw materials needed to produce drugs and problems at the plants themselves, like in the case of factories damaged by extreme weather.

Both bills under consideration would require companies to notify regulators up to six months in advance of any "planned disruption," and, "as soon as practicable," for unplanned occurrences.

Another legislative measure could be a reform of the way companies are reimbursed for use of the drugs through Medicare. Currently manufacturers report the average sales price of their products to federal regulators, who reimburse them with 6 percent of that figure; here's Farber.

"There's not much incentive for some of the companies to make some of these drugs because the reimbursement is so low. So something that Congress could potentially look at is changing the way some of these generic injectables are reimbursed so there's more incentive."

The FDA has scheduled a public meeting with stakeholders to address the issue for September 26, due in part to the request of Connecticut U.S. Senator Richard Blumenthal, a co-sponsor of the Senate bill.

Blumenthal sent a second letter to U.S. Secretary of Health and Human Services Secretary Kathleen Sebelius in June asking that the meeting be expedited.

Blumenthal and New York U.S. Senator Chuck Schumer, who is also a con-sponsor of the Senate bill, were not available for comment Thursday morning.

Congressman John Olver of Massachusetts' 1st-district and Congressman Chris Gibson of New York's 20th-district did not return requests for comments Thursday morning.