Tag Archives: FDA

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CONGRESS: the Republican led House keeps taking days off – the Senate considers S.3187,FDA user fees


the Senate Convened at 9:30amET May 23, 2012

  • Following the prayer and pledge, the Majority Leader will be recognized. It is his intention to resume consideration of the motion to proceed to S.3187, the FDA user fees legislation.
  • Following the remarks of the Majority Leader and the Republican Leader, the first hour will be equally divided and controlled between the two sides with the Republicans controlling the first half and the Majority controlling the final half.
  • At 11:00am, the motion to proceed to S.3187 will be adopted, the Harkin-Enzi substitute amendment will be agreed to and considered original text for the purposes of further amendment. The Majority Leader will then be recognized.
  • Additionally, the Majority will control the time from 1:00pm until 2:00pm.
  • We are working on an agreement for amendments to the FDA user fees legislation.  We hope an agreement can be reached without filing cloture on the bill.  Senators will be notified if an agreement is reached and when votes are scheduled.

By consent, the previous order to adopt them motion to proceed to S.3187, the FDA bill, has been delayed until 12:30pm today. The Majority Leader will be recognized prior to adoption of the motion to proceed.

By consent, the previous order to adopt them motion to proceed to S.3187, the FDA bill, has been delayed until 2:15pm today. The Majority Leader will be recognized prior to adoption of the motion to proceed. As a reminder, the previous order is to adopt the motion to proceed and agree to the Harkin-Enzi substitute amendment by consent.

The Senate has reached an agreement to limit amendments to S.3187, the FDA bill, to those amendments listed below. No other amendments are in order. There will be 30 minutes for debate on each amendment, except for the McCain amendment, and 60 minutes on the bill, both equally divided in the usual form. There will be 2 hours equally divided on the McCain amendment #2107.

At 2pm on Thursday, May 24, all debate time will be considered expired and the Senate will proceed to vote in relation to the amendments in the order listed. Amendments are subject to a majority vote except where noted with a 60 affirmative vote thresholds. There will be 2 minutes for debate prior to each vote. All votes after the first vote will be 10 minutes in duration. No motions or points of order are in order to the amendment or the bill other than budget points of order and the applicable motions to waive or motions to table. Upon disposition of the amendments, the Senate will proceed to vote on passage of S.3187, as amended.

Further upon disposition of the FDA bill, the Senate will proceed to the consideration of S.2343, the Student Loan interest rate bill. There will be 10 minutes for debate prior to a series of 2 roll call votes. The first, in relation to McConnell, or designee, amendment, which is identical to the text of S.2366, and then on passage of S.2343, as amended, if amended. The amendment and bill are subject to 60-vote thresholds. No motions or points of order are in order to the amendment or the bill other than budget points of order and the applicable motions to waive. If the bill does not achieve 60 affirmative votes, S.2343 will be returned to the Calendar.  Senator Reid’s previously entered motion to reconsider the failed cloture vote is withdrawn.

Amendments in order to the FDA bill:

– Bingaman #2111 (generic filings) (60-vote threshold)**;

– McCain #2107 (reimportation) (60-vote threshold)**;

– Sanders #2109 (criminal fraud/exclusivity) (60-vote threshold)**;

– Murkowski #2108 (genetically engineered salmon) (60-vote threshold)**;

– Cardin #2125 (health benefits/risks);

– Cardin #2141 (FDA report – small business);

– Grassley #2121 (whistleblower protections III);

– Grassley #2129 (GAO report – clinical trials);

– Manchin #2151, as modified [or new version??] (reclassifying hydrocodone under Controlled Substances Act)**;

– Portman #2146, as modified (Synthetic drugs – controlled substances);

– Portman #2145, as modified (Rx drug monitoring);

– Reed #2126 (Sunscreen testing/labeling); and

– Coburn #2132 (FDA employee performance standards)**;

– Coburn #2131 (Drug Application Review Process)**;

– Durbin #2127 (dietary supplements)**;

– Paul #2143 (supplements)]**;

– Burr #2130 (Congress – user fee negotiations)**.

** indicates the most likely targets for roll call votes.

The following amendments are pending to S.3187, the FDA user fees bill:

The following amendments have been considered to S.3187, the FDA user fees bill:

  • Harkin-Enzi amendment #2122 (substitute); agreed to by unanimous consent
  • Cardin amendment #2125 (health benefits/risks); agreed to by unanimous consent
  • Cardin amendment #2141 (FDA report-small business); agreed to by unanimous consent
  • Grassley amendment #2121 (whistleblower protections III); agreed to by unanimous consent
  • Grassley amendment #2129 (GAO report – clinical trials)
  • Manchin amendment #2151, as modified (reclassification of hydrocodone under Controlled Substances Act); agreed to by unanimous consent
  • Reed amendment #2126 (Sunscreen testing/labeling); agreed to by unanimous consent

WRAP UP

No ROLL CALL VOTES

LEGISLATIVE ITEMS

Discharged the Banking committee and passed S.2367, a bill to strike the word “lunatic” from Federal law, and for other purposes.

Passed H.R.4097, the John F. Kennedy Center Reauthorization Act of 2012.

Completed the Rule 14 process of S.3220, the Paycheck Fairness Act. (Mikulski and others)

Completed the Rule 14 process of S.3221, the Rewarding Achievement and Incentivizing Successful Employees Act. (Rubio and others)

No EXECUTIVE ITEMS

————————————————————————————————–

The next meeting is scheduled for 10:00 a.m. on May 25, 2012.

~ politics petitions pollution and pop culture

Tell Congress to fix … The medical-device safety bill

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Today's consumer action:

Fix the Flaw!The medical-device safety bill is coming up for a major vote, and it still has a gaping loophole! Tell your Senators to Fix the Flaw!Take action

You wouldn’t buy a new car with a known safety defect. You’d expect the problem to be fixed first.

So why is Congress planning to let medical device manufacturers keep selling implants – from hip replacements to heart defibrillators to surgical mesh – without having them fix the safety flaw first?

Tell your Senators and Representative: Fix the Flaw!

This week the Senate could vote on the bill that sets safety standards for the medical device industry. Lobbyists have managed to keep this gaping safety loophole from being fixed in the bill, and we need consumers to speak out today before it’s too late.

Manufacturers love the loophole because they can put an implant on the market just by showing that it’s ‘substantially equivalent’ to one already approved – even if the implant they’re modeling it on was recalled for safety problems! And the FDA can’t make the company prove they’ve fixed the flaw or do clinical safety testing before the device is sold to you!

The consequences are serious. Tens of thousands of women have various vaginal mesh implants inside them based on a 1999 recalled product. Last year the FDA warned about bleeding, infections and organ perforation from the mesh deteriorating, and many women require multiple surgeries to repair the damage. The FDA should have the authority to demand flaws like these be fixed before allowing the devices to be sold.

Congress: Fix the Flaw with medical devices, and hold industry responsible for safety!

It’s important you get your Senators’ attention on this matter, or the loophole might just slip quietly through. Consumers’ emails have already made the safety bills stronger, so please forward this to others so they can add their voice to this critical issue.

Sincerely,
Lisa McGiffert, SafePatientProject.org

~ politics petitions pollution and pop culture

Pesticides are killing bees

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Pesticides are killing bees and threatening our food supply. In 24 hours, shareholders at the biggest chemical producer, Bayer, could vote to stop their toxic production. Massive public pressure has forced this debate at their Annual General Meeting, now let’s make sure they vote to stop the pesticides and save the bees. Sign the emergency petition:

 

Quietly, globally, billions of bees are dying, threatening our crops and food. But if Bayer stops selling one group of pesticides, we could save bees from extinction.

Four European countries have begun banning these poisons, and some bee populations are already recovering. But Bayer, the largest producer of neonicotinoids, has lobbied hard to keep them on the market. Now, massive global pressure from Avaaz and others has forced them to consider the facts — and in 24 hours, Bayer shareholders will vote on a motion that could stop these toxic chemicals. Let’s all act now and shame the shareholders to stop killing bees.

The pressure is working, and this is our best chance to save the bees. Sign the urgent petition and send this to everyone — let’s reach half a million signers and deliver it directly to shareholders tomorrow in Germany!

http://www.avaaz.org/en/bayer_save_the_bees/?vl

Bees don’t just make honey, they are vital to life on earth, every year pollinating 90% of plants and crops — with an estimated $40bn value, over one-third of the food supply in many countries. Without immediate action to save bees, many of our favourite fruits, vegetables, and nuts could vanish from our shelves.

Recent years have seen a steep and disturbing global decline in bee populations — some bee species are already extinct and some US species are at just 4% of their previous numbers. Scientists have been scrambling for answers. Some studies claim the decline may be due to a combination of factors including disease, habitat loss and toxic chemicals. But increasingly, independent research has produced strong evidence blaming neonicotinoid pesticides. France, Italy, Slovenia and even Germany, where the main manufacturer Bayer is based, have banned one of these bee killers. But, Bayer continues to export its poison across the world.

This issue is now coming to the boil as major new studies have confirmed the scale of this problem. If we can get Bayer shareholders to act, we could shut down once and for all Bayer’s influence on policy-makers and scientists. The real experts — the beekeepers and farmers — want these deadly pesticides prohibited until and unless we have solid, independent studies that show they are safe. Let’s support them now. Sign the urgent petition to Bayer shareholders now, then forward this email:

http://www.avaaz.org/en/bayer_save_the_bees/?vl

We can no longer leave our delicate food chain in the hands of research run by the chemical companies and the regulators that are in their pockets. Banning this pesticide will move us closer to a world safe for ourselves and the other species we care about and depend on.

With hope,

Alice, Antonia, Mia, Luis, Ricken, Stephanie, Pascal, Iain, Ari and the whole Avaaz team

MORE INFORMATION

Studies fault Bayer in bee die-off (Christian Science Monitor) http://www.csmonitor.com/Science/2012/0406/Studies-fault-Bayer-in-bee-die-off

2 Studies Point to Common Pesticide as a Culprit in Declining Bee Colonies (New York Times) http://www.nytimes.com/2012/03/30/science/neocotinoid-pesticides-play-a-role-in-bees-decline-2-studies-find.html?_r=1

Leaked document shows EPA allowed bee-toxic pesticide despite own scientists’ red flags (Grist) http://grist.org/politics/food-2010-12-10-leaked-documents-show-epa-allowed-bee-toxic-pesticide/

Bayer’s Annual Stockholder’s Meeting (ASM website) http://www.asm2012.bayer.com/en/counter-motions.aspx

~ FDA/USDA ~~ Alerts & Safety, ~ politics petitions pollution and pop culture

Smell something fishy at the FDA?


Change.org

Tell the FDA you have the right to know when your food is genetically modified. 

Sign the Petition

The first genetically engineered (GE) meat approved for human consumption might soon be on its way to a supermarket near you – a fast-growing salmon developed by a company called AquaBounty Technologies.

But it gets fishier. If AquaBounty’s GE salmon is approved for sale, the FDA might decide to put it right next to normal salmon in the meat case, without any special labeling. Consumers would be none the wiser.

We deserve to know if the meat on our plate is genetically engineered or not. Companies and FDA officials shouldn’t keep us in the dark about the foods we eat or feed to our families.

Tell the FDA you want labels on genetically engineered foods so you can make an informed choice.

No labeling is a dangerous precedent to set for genetically modified foods. Recent drug recalls have shown us that just because the FDA approves something doesn’t mean it’s safe in the long term. Any adverse effects of genetically modified meat on people might not show up until it’s already been consumed by a large number of Americans. And by then it’s too late. Without labeling, it will be even harder to recognize and track problems that might be caused by GE foods.

AquaBounty Technologies’ own scientists are telling the FDA that its GE salmon is perfectly safe. But there’s no way they can prove these claims, and we can’t dump unlabeled GE salmon into the food supply on the word of the company that stands to make a profit.

The FDA is being heavily lobbied by AquaBounty Technologies about its forthcoming decision, and now needs to hear from concerned consumers like you about whether GE salmon should be labeled or not.

Tell the FDA to require labeling of genetically engineered salmon so that consumers can decide for themselves whether to buy and eat it.

It’s up to the FDA to keep our food supply safe, and it’s up to us to let the FDA know where consumers stand on GE foods.

Thanks for taking action

– The Change.org Team