Senate Passes Drug Shortages Bill

The US Senate by a vote of 96-1 finally passed, as part of the FDA User Fees reauthorization bill, portions of the Senate Bill 296 (the Preserving Access to Life-Saving Medications Act) today to require drug companies to give 6 months notice of potential drug shortages.
http://www.nytimes.com/2012/05/25/us/politics/senate-passes-bipartisan-bill -on-new-medicines.html
http://www.cbsnews.com/8301-250_162-57441191/senate-passes-drug-import-safe ty-bill/
Thanks to everyone who contacted their senators to support legislation to help end the drug shortages!

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7 replies. Join the discussion

Scooby, This is great news. Thank you so much for your advocacy! what's next?

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Ovarian cancer patients contacting their Senators made a difference!! http://www.sacbee.com/2012/05/25/4515699/senate-oks-bill-for-faster-drug.ht ml

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Oh thank God.

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But did it prohibit them from the monkey business we saw with Doxil?

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I had my first Lipodox tx on Friday and asked the chemo nurse about the mechanism of the drug. She referred me to the pharmacist who came down to the infusion room to speak with me. She was very enthusiastic about it. When I told her what you had posted about the new bill and it's passage, she was pleased and gave me a little more information about what happened when Doxil was shut down. Apparently the FDA inspector had been warning them for a long time that there were problems but Bedford (the mfg company that I believe is subsidiary of J &. J) only fixed the minor problems. FDA did not act on big problems. When another inspector came in last summer, that is when they were finally closed down and forced to retrofit the plant. Shame on FDA for not being more forceful in its warnings and shame on J & J for not spending the bucks to make their plant safe.

The pharmacist also told me there were only 7 inspectors for the entire US. President Obama, by decree, has doubled the number of inspectors. Good for him! Still doesn't seem enough but it is an improvement.

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I still haven’t figured this one out. It’s SB 3187.

Depending on what you search for you will find different descriptions/headlines of the bill. I didn’t even realize the media was talking about the same bill.

In addition to the two listed by Scoobydoobeach, there is this side of the bill:

FDA User Fee Bill Gets Senate OK:
http://www.medpagetoday.com/Washington-Watch/Washington-Watch/32941

U.S. Senate passes bipartisan FDA funding bill:
http://www.msnbc.msn.com/id/47558302/ns/health/t/us-senate-passes-bipartisa n-fda-funding-bill/#.T8JwNFKuXvY

Much depends on which amendments go with it:
http://democrats.senate.gov/2012/05/24/amendments-to-s-3187-the-fda-user-fe es-bill
“The following amendments have been considered to S.3187, the FDA user fees bill:”

To my knowledge the lone dissenter did so because the bill apparently does nothing to hold down drug costs.

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It appears they took part of Senator Klobuchar's bill and incorporated it into (or tacked it onto) the FDA User Fees bill which had to be reauthorized. So the part that affects drug shortages is the requirement that the drug companies inform the FDA 6 months in advance of any suspected drug shortages. I believe it appears in the Harkin-Enzi amendment included the part about drug shortages. Look at Title X
http://thomas.loc.gov/cgi-bin/query/D?r112:1:./temp/~r112xnQYVi:e392299:

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