Cancer drug shortages continue to confound the best efforts of the FDA to head them off, in part because the agency has little authority to address what causes them to occur, according to a co-author of an attention-getting study about shortages.

Dr. Keerthi Gogenini, a medical oncologist with the Abramson Cancer Center at the University of Pennsylvania, helped present one of several studies that grabbed headlines at the June meeting of the American Society of Clinical Oncology. Evidence-Based Oncology checked back with Gogenini and with the FDA on the current state of shortages for its August issue.

An FDA spokeswoman, Lisa Kubaska, PharmD, credited the 2012 Food and Drug Safety Innovation Act with allowing the agency to identify shortages and find temporary solutions, such as importations of drugs. But Gogenini said on the front lines, the picture is not that rosy, although she believes the FDA is doing what it can.

“There are factors that contribute to drug shortages that the agency has limited control over,” Gogenini said.

The FDA, Gogenini and multiple other experts attribute cancer drug shortages to quality control problems at large manufacturers. The trouble is, the FDA cannot force drug manufacturers to direct manufacturing resources to generics instead of branded drugs, which cost more. The 2012 legislation basically serves as an early warning system that gives the FDA time to come up with alternatives when a shortage looms.

The June surveys presented at ASCO, including the study conducted at the University of Pennsylvania, showed widespread effects of shortages. In the Penn study, 94 percent of oncologist and hematologists said patients’ treatment had been affected by shortages, and 13 percent reported that patient participation in clinical trials had been compromised.

Gogenini attributes shortages to the lack of redundancy across the manufacturing system, while others have blamed the low cost of generics, which give companies little incentive to invest in capacity for these drugs.

“There are few penalties for failing to supply critical drugs, and no incentive for companies to invest in ‘excess’ capacity,” Gogeini told EBO. “This is not something the FDA would have control over.”

1 Comment

  • Robert Orzechowski says:

    The drug shortages, especially in cancer care, should have been expected once the perverse ASP reimbursement model and 340b pricing were forced upon us.
    Any time a price ceiling is placed on a commodity, a shortage is inevitable.
    Drug price increases have not been controlled either, as was a sstated goal of the ASP model.
    Manufacturers have simply become sophisticated at managing their contacts with distributors (basically 2 large and 1 or 2 much smaller ones). The history of price changes shows regular increases on an annual or semi-annual basis for the majority of cancer drugs.
    While some QC problems do contribute to shortages (in any process), this can only explain a portion of the situation.
    Given the sophisticated processes and technology required to bring these complex commodities to market, production problems are inevitable.
    However, government imposed financial, regulatory and administrative compliance burdens at every stage of the value chain must shoulder their share of the blame.
    Importation is a dangerous path for such critical products and is an irresponsible reaction to a situation created in large measure by the ASP and 340b regulations, patent laws etc..
    What is needed are more market focused solutions, not more government “solutions” [sic].
    Biotechnology is perhaps the only robust manufacturing industry left standing in America. It is populated with perhaps the brightest minds in the labor force.

    Get out of their way. If what they bring to the market is unsalable, they’ll figure out a solution more often than not.
    How productive is this industry in more socialized countries?
    But as long as governments at all levels continue to interfere in their many creative ways, including arbitrary reimbursement models, we can expect only more of the same we have now.
    More government in not the solution; it is the problem.
    It seems like the sources cited in the article think the government should be able to force private firms to produce products the government deems necessary, that private firms should be punished for having limited [efficient]capacity, and penalized for not producing what Big Brother demands.
    What’s next, state-owned enterprises (those paragons of efficiency)?

    I’ve spent 24 years in oncology and have seen first hand the delivery of care at the community setting. I speak from in-depth experience trying to manage the business and human sides of treating cancer patients, and until we have a true, candid dialog on the issue of health care as a right or a commodity, we will continue to waste recources and grapple with the deleterious effects of salaried academitians, bureaucrats and elected officials who will never be affected by the impact their controls and other regulations on the rest of us.

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