Supporters of pending legislation on drug shortages face a challenge of time – demonstrating that the extra time the advance-warning system would provide is worth the legislative time and effort to create it.

Hospital and pharmacy groups are pushing the bill to provide FDA more authority over dealing with drug shortages. On July 12, the American Hospital Association and American Society of Health-System Pharmacists released survey data outlining the number of facilities affected, the added costs and additional man-hours needed to manage them.

The hope is an early warning can allow time to plan for a shortage, such as finding alternative sources or drugs to meet the demand. However, the bill, versions of which are pending in both chambers, does not give FDA much power to actually prevent or stop a shortage.

Having the information certainly would help the hospitals and pharmacies affected by a shortage. The question remains whether that information will prevent the effects of a shortage that were outlined in the AHA survey, including drug rationing, purchasing more expensive or less effective alternatives and not providing the recommended treatments.

Sen. Klobuchar argues FDA has a track record of fixing shortage problems when it has the information early enough.

Sen. Amy Klobuchar, D-Minn., a co-sponsor of the Senate version, said FDA has a track record of fixing shortage problems when it has the information early enough.

“Once you start requiring notification … that can also have a preventative effect as companies start realizing that they’re going to have to, way ahead of time, notify the FDA that they have one of these factors occurring,” she said during the AHA/ASHP press conference discussing the survey results.

“And then it also creates new marketplaces when it gets out there that a certain drug shortage exists. Sometimes information can empower a marketplace and to me that’s part of this as well,” Klobuchar said.

The House version of the bill, sponsored by Rep. Diana DeGette, D-Colo. and Rep. Tom Rooney, R-Fla., specifically prevents FDA from forcing a manufacturer to produce a drug in the event of a shortage or supply interruption.

The agency instead would be left to persuade other manufacturers to ramp up production, if possible. Klobuchar said FDA already engages in the practice when it knows about a shortage.

The House bill, which is much more detailed than Klobuchar’s version, also does not permit FDA to share certain details included in the notice.

Importation As A Shortage Solution

Klobuchar also indicated during the press conference that one solution could be “more permanent” importation of drugs in the case of a shortage.

She made clear that such a provision was not in the bill, but indicated the issue could be a vehicle for the controversial idea.

“It’s not included in this bill because of the fact that we want to get a targeted response to this very clear problem about drug shortages,” Klobuchar said.

Drug reimportation could come up during the Prescription Drug User Fee Act reauthorization debate next year and potentially slow its passage (Also see "What’s In A PDUFA Reauthorization? Maybe These Issues…" - Pink Sheet, 11 July, 2011.).

DeGette also said some of the reasons shortages occur are not easily fixed with legislation. She said once the early warning system is implemented, she and others will continue to work with industry to address the systemic problems that create shortages.

Incentives To Make Vulnerable Drugs

The bill would require manufacturers to give at least six months' notice before planning to stop making a drug temporarily or permanently. Unexpected interruptions also would require a six-month notice or as early as practicable.

Today only sole-source manufacturers of medically necessary drugs are required to give a six-month notice before discontinuing production.

The House version of the bill also requires identification of drug supplies susceptible to a shortage and the writing of contingency plans. In addition, fines for failing to give proper notice were set at $10,000 per day, with the total fine not exceeding $1.8 million for violations adjudicated in a single proceeding (Also see "Drug Shortage Legislation Gains Momentum With Bipartisan House Bill" - Pink Sheet, 27 June, 2011.).

“I think that it’s the responsible thing to do to ask these manufacturers just to give a heads-up so that hospitals and doctors and pharmacists aren’t operating in the dark,” Rooney said.

Doctors "are going to potentially exhaust drug supplies if they have them and if that situation is going to change, they need to be able to, as we said in the Army, adjust fire accordingly,” he said.

AHA and ASHP also recommended a number of incentives to encourage manufacturers to prevent shortages or stoppages, such as tax credits for facilities that agree to continue producing drugs vulnerable to a shortage. The groups also suggested FDA consider allowing priority approval for manufacturers who create redundant production lines for drugs prone to shortages.

They said FDA should create a shortage classification system so it can focus its resources on the most pressing events and improve communication between FDA offices and manufacturers and health professional associations.

The agency also could allow fast-track approval of new production lines, alternative manufacturing sites or new API suppliers during shortages of drugs considered medically necessary, the groups said.

Hearings Being Pushed In Both Chambers

AHA and ASHP increased the pressure on legislators to act on the bill with the survey information. They said more than three-quarters of respondent hospitals had to ration or put restrictions on drugs in short supply. They also said labor costs to manage shortages amount to about $216 million in annual impact nationwide.

Efforts are ongoing to gain hearings in both chambers. Klobuchar said a bipartisan working group is trying to move the bill in the Senate, while DeGette said she is working to gain a hearing in the House Energy and Commerce Committee.

It also is possible the bill will be included in legislation reauthorizing PDUFA, although ASHP recommended against waiting until 2012, when that legislation needs to pass.

The prospects of passage will decrease as the 2012 presidential election draws closer. Observers and congressional staff hope PDUFA passes by next summer in order to keep presidential politics from affecting the process (Also see "Not Another FDAAA – Observers Expect Fewer FDA Reforms In PDUFA V" - Pink Sheet, 11 July, 2011.).

By Derrick Gingery

Drug Shortages Are A Matter Of Time As Bill Sponsors Work To Show Warnings Will Help

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