Drug Shortages Persist, Despite Government Efforts

Roxanne Nelson

August 22, 2013

Despite government efforts and stopgap measures, drug shortages continue to persist in the United States, according to a new report.

The shortages include those in oncology, despite pronouncements from the government that state otherwise, according to Keerthi Gogineni, MD, MSHP, of Abramson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.

She is referring to an article published online in Evidence-Based Oncology (EBO), a supplement of the American Journal of Managed Care..

In the EBO report, Lisa Kubaska, PharmD, a spokesperson for the US Food and Drug Administration (FDA), notes that the 2012 Food and Drug Safety Innovation Act (FDASIA) has allowed the agency to identify shortages and find at least temporary solutions, including importing drugs from overseas.

But Dr. Gogineni, a medical oncologist, says that the "picture is not that rosy" for those working on the front lines of medicine. However, she does believe that the FDA is doing the best they can, given the limits of their authority in this issue.

The 'picture is not that rosy' for those working on the front lines of medicine. Dr. Keerthi Gogineni

Dr. Gogineni is the lead author of a survey that was presented at the recent annual meeting of the American Society of Clinical Oncology (ASCO) that highlighted the continuing sporadic shortages of cancer drugs and the negative effect that they were having on patient care. She said the problem continues today, 2 months after the data were presented.

Differing Perspectives

In the EBO report, Dr. Kubaska notes that there has been 1 new shortage in 2013, of lomustine (CeeNU, NextSource Biotechnology, LLC) tablets. However, this was "resolved through import of a drug with unapproved packaging until the approved package could be made available."

Dr. Gogineni offers a different viewpoint on the issue. In her own practice, they have had "considerable difficulty acquiring this drug to treat patients with brain tumors. There is an ongoing attempt to obtain this drug by enabling NextSource Biotech [the manufacturer] to import the product but under a different trade name."

Theoretically, this should have made emergency supplies of the drug easier to obtain by July 2013, Dr. Gogineni notes, "but practically speaking, this has not been the case."

Both Dr. Kubaska and Dr. Gogineni are in agreement over the cause underlying the majority of shortages, in that they are due to quality control problems at several of the large manufacturing plants. Preventing shortages is a "top priority" for the FDA, contends Dr. Kubaska, and that passage of FDASIA has enhanced the agency's ability to anticipate potential drug issues via a new early notification system.

But this does not appear to be sufficient. "There are factors that contribute to drug shortages that the agency has limited control over," says Dr. Gogineni.

Combo of Factors

As previously reported by Medscape Medical News, an executive order signed by President Barack Obama and later the passage of FDASIA directed the FDA to broaden its reporting of potential drug shortages, which would theoretically give the agency sufficient time to prevent or reduce them. With early notification, the FDA can work with manufacturers to more quickly address quality issues that stifle production, along with finding additional companies to help increase drug output.

At the 2012 ASCO annual meeting, Sandra Kweder, MD, deputy director of the Office of New Drugs at the FDA, pointed out that the generic versions of sterile injectable cancer medications are most prone to shortages, which are often caused by manufacturing and quality problems.

For example, during a discussion held at the meeting, she said that one manufacturer recently discontinued production when metal shavings or particles of glass were detected in a product. Thus, the closure of even a single facility, even temporarily, can lead to shortages.

Dr. Kweder had emphasized that progress has been made, explaining that 50 drug shortages had been prevented since October 2011; in 2012, another 50 were prevented, simply because of early notification from manufacturers.

But shortages can also be attributed to other factors, including industry consolidation, increases in demand, and a lack of access to pharmaceutical ingredients. In a previous interview, Dr. Gogineni told EBO that "there are a combination of underlying reasons."

"There is little redundancy in the system," she said, and there is "a marked increase in new sterile injectable product applications without a concomitant increase in manufacturing capacity [which] has led firms to divert production to more expensive, branded agents."

Although the FDA is authorized to address quality issues, it is limited in its ability to increase manufacturing capacity. The agency can expedite reviews of "new" manufacturers, but it can take years for a manufacturer to boost up their capacity, says Dr. Gogineni. There are also few penalties for failing to supply critical drugs, and incentives for companies to invest in excess capacity are nonexistent.

"This is not something the FDA would have control over," she says.

Needs More Teeth

Richard Schilsky, MD, professor of medicine at the University of Chicago, Illinois, who also spoke on the subject during the 2012 meeting, agrees that "more" is needed.

ASCO is seeking a permanent solution to the problem of drug shortages, but this would probably require an act of Congress, according to Dr. Schilsky. Even though the FDASIA requires drug manufacturers to notify the FDA 6 months in advance of market withdrawals or manufacturing interruptions, it does not go far enough.

Dr. Schilsky, who is also a past president of ASCO, said that the association wants Congress to require manufacturers not only to give the FDA early warning of impending shortages but to also have some sort of penalties or fines for companies that do not comply.

The reporting requirement is in the legislation, but the penalties are not, Dr. Schilsky noted. "If there are no teeth in that legislation, some companies may decide not to report as required," he said.

American Journal of Managed Care: Evidence-Based Oncology. Volume 19, special issue 6, July/August 2013. Full text


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