Every day, increasing numbers of patients learn that a chemo - therapy has been developed that could save their lives, but the drug they need is unavailable, because no one is manufacturing it. Expensive to man ufacture, yet priced very low, generic sterile injectable chemotherapies are some of the drugs that are the most vulnerable to production shortages.
However, thanks in part to the efforts of physicians, patient groups, and provider groups such as the Association of Community Cancer Centers (ACCC), critical drug shortages have received much-needed attention from the media and by Congress.
The ACCC recently signed a coalition letter with other stakeholders, urging the US Congress to act now to stem the crisis. Many ACCC members have submitted letters to their legislators on Capitol Hill, and some have even had letters to the editor published in their local newspapers. With our current hyperpartisan Congress—where only the most necessary legislation moves—the volume on the drug shortage crisis has risen to a level where Congress agrees that action must be taken.
A few approaches have been put forward as potential solutions to alleviate the drug shortage crisis. First, Senator Amy Klobuchar (D-MN) introduced the S. 296 bill in the Senate, which gained bipartisan support from 30 cosponsors. This bill shifts the responsibility for reporting drug shortages from physicians to manufacturers. The legislation would require manufacturers to report impending drug shortages to the US Food and Drug Ad - ministration (FDA). The bill is designed to give providers more notice of upcoming shortages and encourage manufacturers to avoid unnecessary production stoppages.
The House of Representatives soon followed with its own version of the bill, H.R. 2245, introduced by Rep Diana DeGette (D-CO). In addition, H.R. 3839, introduced by Rep John Carney (D-DE) and Rep Larry Bucshon (R-IN), is legislation that would grant the FDA authority and resources to expedite the approval process for new companies that manufacture drugs facing shortages. Although these bills treat some of the symptoms of drug shortages, most experts agree that these bills do not reach the root cause of the problem.
Many believe that we will not see a significant reduction in the shortage crisis until we address how the manufacturers producing these critical drugs are reimbursed. Senator Orrin Hatch (R-UT), member of the Senate Finance Health Sub-committee and ranking member on the Finance Committee, is expected to introduce legislation that seeks to alleviate shortages through economic incentives. This legislation de fines drugs in critical shortage as being generic sterile injectable drugs with less than 5 active manufacturers.
This bill would grant 5 years of exclusivity to manufacturers that produce drugs to alleviate a shortage and would alter the reimbursement structure for those drugs. For drugs with only a single manufacturing source, Medicare reimbursement would be based on the wholesale acquisition cost. For drugs with multiple production sources, payment would be based on a volume-weighted average of the wholesale acquisition cost.
Because of the difficulty of moving independent legislation to passage in Congress, elements of these bills are expected to be incorporated into the Prescription Drug User Fee Act (PDUFA) reauthorization. Because the PDUFA regulates how manufacturers bring drugs to market, it is one of the few bills that must pass in 2012.
Legislators generally view the drug shortage issue as germane to the PDUFA as a whole, so it is probable that we will see language that shifts reporting requirements, and grants the FDA the necessary resources to have manufacturers that produce drugs in short supply continue to manufacture those drugs.
Although the oncology provider community remains hopeful that components of Senator Hatch’s approach will make it into broader FDA regulation, at this point it is still unclear what will happen.
The ACCC has been on the forefront of the drug shortage crisis, and it continues to work with providers and legislators to find a meaningful solution to this critical issue.