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Shortages, what shortages?

By Joseph Hill posted 07-29-2011 13:51

  

As July winds down and the lazy days of summer lead us into prime vacation season, I’m left wondering where the buzz around drug shortages went.  I’m not talking about in Congress-- even though raising the debt ceiling is appropriately the number one issue on the Hill right now there is still some action on drug shortages here in DC.  My question or questions rather are aimed outside the “beltway” to the rest of America. Are drug shortages history?  Is this pharmacy’s version of the Gulf oil spill where we went from crisis to calm almost overnight?

It’s hard to believe that with 193 drugs on the current shortage list and the impact that shortages have on patient care that our members don’t want their Members of Congress to support H.R. 2245.  This is a bipartisan (yes I said it) bill that creates an early warning system where manufacturers must notify FDA when production interruptions occur that may result in a drug shortage situation.  This bill is not just the House version of a Senate bill introduced earlier this year, S. 296.  It is a more refined bill that was developed with input from an array of stakeholders, including a manufacturer.  The bill covers biologics not just drugs, and specifically lists the civil monetary penalties manufacturers would be subject to if they fail to notify FDA.    

This bill isn’t going to completely do away with shortages, but it is such a good first start, a manufacturer is supporting it.  And of course, ASHP submitted a joint letter of support as part of a coalition that’s been really pressing this issue. 

There’s a lot of activity going on-- Hill briefings, significant media coverage and the formation in the Senate of a bipartisan (there I go again) working group to address this issue.  But ASHP members aren’t speaking up.  

The truth is, August is a vacation month, but it is also time that members of Congress are home in their districts and states, and is therefore a critical time for you, their constituents, to engage them one-on-one and through sending letters, setting up site visits, attending town halls, or writing op-eds.  Assuming a deal is made on the debt ceiling, Congress will need an issue that is bipartisan to show an angry public that it can still work together in the public’s interest. 

So take a minute and log on to our grassroots web site and send an e-mail urging your representative to take immediate action on H.R. 2245.  Then enjoy your well-deserved vacation. 

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08-16-2011 08:37

The bill is a first step and additional solutions, including market incentives are needed as well. Market incentives will however, require input from the manufacturer community. Unfortunately there is no single solution that will solve this problem overnight. Further, I understand the concern over additional government regulation, but when FDA cites that 38 shortages were avoided in 2010, it does indicate this will make a difference. We can't let perfect be the enemy of good.

08-02-2011 16:26

Maybe I'm wrong, but increased government involvement seems like the last thing we need when it comes to drug shortages. I know the legislation makes it sound like the FDA will fix these shortages, but I'm afraid it will just lead to more red tape and unwarranted meddling in the supply of medications. More government involvement is not the answer.

08-02-2011 10:27

I agree that we all need to get behind this legislation. Akin to supporting motherhood and apple pie. Will it solve very much? With one manufacturer on board prospects seem less than rosy.
Is funding going to be assured for the FDA so that their enforcement of regulations will be consistent? Again prospects are dim. Is profitability of vital generic agents going to be adequate so that supplies are consistent? Maybe. Rest assured that prices for them will rise (if &) when they return. Are we going to ensure the safety and efficacy of every source manufacturer, particularly those in Asia? So many issues, so few effective tools.