FDA would like additional funding for a number of its programs, but it does not appear that the agency will be pushing to expand its drug shortage team.

The agency had four people, and recently added a fifth, dedicated to dealing with drug shortages, in addition to coordinator Ed Cox, who also is the director of the Office of Antimicrobial Products.

As more attention is paid to dealing with the rising number of new shortages, some have asked whether FDA should devote more resources to the prevention and mitigation effort.

Sandy Kweder, deputy director of the CDER Office of New Drugs, said the agency is not really interested in adding people to fight shortages.

“We don’t want to have a big drug shortages staff,” she said during a Sept. 26 FDA drug shortage workshop. “We will if we have to, but that’s not our goal. We’re not into empire building on the drug shortages staff here at FDA. We want this to not be a public health problem.”

Kweder’s statement may stem at least in part from a hope that the advancing tide of drug shortages eventually will recede. She told the House Energy and Commerce Subcommittee on Health Sept. 23 “resources matter” when trying to mitigate shortages, because “these are not automated processes.”

But Kweder said later at the workshop she did not want to be forced to allocate more resources for shortage issues.

“The less that FDA has to do, the better, as far as we’re concerned, in this area because … we have other work to tend to,” she said. “This is extraordinarily important, but it should be able to be prevented.”

Many presenters at the workshop showered praise on the drug shortage staff for its work. In 2010, FDA said it prevented 38 drug shortages (see sidebar, Also see "38 Special: How FDA Shot Down Drug Shortages In 2010" - Pink Sheet, 3 October, 2011.).

This year, they already have upped the total to 99 shortages prevented, in part because more manufacturers are warning the agency of a production interruption well in advance.

FDA has argued it can prevent most shortages if it knows about them before they happen, so it can ask other manufacturers to ramp up production or import the affected drug from another country.

A bill co-sponsored by Reps. Diana DeGette, D-Colo., and Tom Rooney, R-Fla., would require manufacturers to give at least six-months notice of a known production interruption and also require continuity plans be developed for drugs vulnerable to a shortage (Also see "Drug Shortage Legislation Gains Momentum With Bipartisan House Bill" - Pink Sheet, 27 June, 2011.).

The bill does not authorize or require additional staff for the drug shortage program. It is unclear whether the bill will be considered, although subcommittee Chairman Joe Pitts, R-Pa., said following the subcommittee hearing he is optimistic it will move to the next step.

A companion bill co-sponsored by Sens. Amy Klobuchar, D-Minn., and Robert Casey, D-Pa., also has been proposed in the Senate.

Practitioners also asked for estimates of the duration and scope of a shortage to plan for the use of alternative therapies (Also see "Drug Shortages: FDA Wants Advanced Warning; Practitioners Want Even More" - Pink Sheet, 26 September, 2011.).

More Than Dedicated Staff Handle Shortages

Stakeholders still suggested more funding and staff should be dedicated to preventing and fighting drug shortages, saying the five people in the drug shortage program may not be enough.

A stakeholder working group on drug shortages, that included representatives of industry, patient advocates as well as physician groups, also indicated FDA should allocate more funding to the program. If the money is not enough, the group suggested more funding be approved to grow the program, although its recommendations are not final yet.

Roslyne Schulman, director of policy development for the American Hospital Association, suggested a “more formal office” as well as a stronger message from the agency’s top management that drug shortages are a national crisis.

The comments may have put FDA on the defensive about its current practices. Ilisa Bernstein, acting director of the CDER Office of Compliance, said FDA devotes resources beyond the shortage team when necessary.

“A lot of what [the drug shortage team members] do is really coordinating and helping and reaching out a lot to [other] organizations, but I can tell you there are a lot of other resources that the agency puts towards helping alleviate and mitigate the drug shortages,” Bernstein said.

The agency also said some of the responsibility rests with manufacturers to ensure they have back-up suppliers at the ready in case of a problem (see related story, Also see "Drug Shortages: Can The Blame Game Help Find Solutions?" - Pink Sheet, 3 October, 2011.).

HHS Exploring Incentives, FDA Exploring Role

Written comments on the impact, causes and solutions to drug shortages will be accepted to the public docket until Dec. 23, according to a Federal Register notice.

A Department of Health and Human Services working group is exploring the financial issues and possible incentives that had been suggested to keep manufacturers from stopping production of shortage drugs, Kweder said.

FDA also is expected to release a report, potentially later this fall, which will include an analysis of the drug shortage problem and make recommendations for the agency’s role.

The report likely will not advise the agency to adjust its regulatory policy. FDA has insisted its facility inspections neither prevent, nor cause, drug shortages.

Quality and/or manufacturing problems involving sterile injectable products, the sector where most shortages occurred, led to the majority of the shortages reported in 2010 (Also see "To Prevent Drug Shortages, Don't Look To Inspections, FDA Says" - Pink Sheet, 22 August, 2011.).

By Derrick Gingery

FDA's Drug Shortages Strategy Focuses On Prevention, Not "Empire Building"

More from Archive

More from Pink Sheet