House drug safety proposal released Posted by Liz at 06/09/07 02:16 PM

So, the long awaited House drug safety draft is out and I think patient groups (not those PhRMA front groups of course) will be pretty psyched about it. The House member that put out this proposal, Rep. Pallone, is the chair of the Health subcommittee of Energy and Commerce.

So, what’s this proposal all about? Some parts of it are stronger than what the Senate passed. First it would require all new drugs to have a warning symbol on their label, to alert the public that some dangerous side effects of the medication may not be known. This is something that the Institute of Medicine recommended in their report that came out last year. It would also allow the FDA to enforce a temporary advertising moratorium for drugs with serious safety risks. (this will be fought tooth and nail by companies that can’t wait to further drive up the cost of health care by pushing out ads for pricey hair loss medications).

And like the bill the Senate passed, it would give the FDA more authority to require follow up safety studies and to change a drug’s label, and the proposal would match the Senate's additional funding for safety.

All great stuff, but how could this proposal really shake up our broken system?..if it gave more authority to the Office of Drug Safety. If the recent Avandia controversy doesn’t show why this is critical, I don’t know what does. An amendment to the Senate bill that would have done this lost by one vote..pretty heart breaking…but this will hopefully push the House to include this reform.

Next week we also expect a committee vote on this proposal. Fingers crossed that our drug safety champs in the House will hold the line on this one, and will drown out industry lobbyists, who will fight to whittle this bill down to something the public will yawn at.

comments (18)

1 Posted by Nancy Free at 06/12/07 10:09 AM

The proposed prescription drug safety bill includes stronger limits on advertising of unsafe drugs, ensuring clinical drug trial results are made public, and limiting conflicts-of-interest on drug advisory committees.

This proposal helps ensure consumers have more information about drug risks, so all of us can make better informed health-care decisions.”

The legislative draft from Rep. Pallone, chairman of the House Energy and Commerce Health subcommittee, is expected to be discussed at a hearing Tuesday, June 12.

The House proposal includes many of the Senate features, including $225 million more in drug industry user fees to help pay for drug safety, and the active monitoring of huge medical databases to detect safety problems. “If such a monitoring system had been in place years ago, the whole Avandia controversy may well have been resolved years earlierDiabetics would have had answers on the safety of this drug within a year or two, rather than drifting for eight years.

The House proposal goes further than the Senate bill by requiring all new drugs display a symbol that they are new to the market; that all new drugs go through a risk evaluation process that can include limiting of direct-to-consumer ads for those drugs with severe and unusual safety issues; and granting only one conflict-of-interest waiver per drug advisory committee.

The drug industry should register and report their clinical drug trials to make them publicly accessible.

The House has the opportunity to pass real reforms that will give the FDA the power to act quickly and decisively when drug safety problems arise,” Vaughan said. “This proposal should help put an end to incidents like Vioxx, where the public was kept in the dark about possible health risks.

2 Posted by Patricia Allen at 06/12/07 10:31 AM

When are we going to stop letting lobbyist and money over rule what is safe for the people of this country. Our countries medical system is broken and only the politicians can fixed it. The question is which ones are going to have the acorns to stand up, stop worrying about how it will affect their career and do what is best for the people. It is sad when you can trust the medications we get because some drug company wants up to be their ginny pigs. We should be able to feel safe , but we don't. The food and drug administration is a worth government office anymore. They are in the pockets of the drug companies. Pleas fix this

3 Posted by Muriel Lawty at 06/12/07 11:24 AM

I have fibromyalgia as well as frequent (2-4/week sometimes)migraines and after doing research, decided to read the side affects of medications and OTC herbal remedies before taking them. Often the side affects are the same as the symptoms! With 2 of the migraine medications, the directions say to call poison control if you think you have taken too much AND neither could claim that it is safe to take more than 4 doses per month. And they cost more that $10 per pill, even with the senior discount. I would not learned this if I had not researched it.

PLEASE MAKE DRUG COMPANIES AND DOCTORS FULLY DISCLOSE RISKS.

Thank you

4 Posted by KMarin at 06/12/07 02:18 PM

Anyone else curious to know how drugmakers and pharmacies can make

Toprol XL 25 mg GENERIC

while

Toprol XL 50 mg is NOT generic????

5 Posted by AMIGO at 06/12/07 03:33 PM

FDA AND LOBBYING REFORM OF 'BIG PHARMA' ARE WAY OVERDUE; WE HAVE HEARD THIS FROM DO-NOTHING LAW-MAKERS FOR DECADES NOW, REPEATED EVERY ELECTION CYCLE.
ALL LOBBYING AND LOBBYISTS (a.k.a CORPORATE P-I-M-P-S ) SHOULD BE BANNED FROM WASHINGTON D.C. AND ANY KIND OF "CONTACT" WITH LAWMAKERS SHOULD BE MADE ILLEGAL. WE NEED TO PUT PRESSURE ON OUR "REPRESENTATIVES" IN CONGRESS TO PASS A LAW TO THAT EFFECT ASAP!
NONE OF THEM SHOULD HAVE ANY PROBLEM WITH THAT IF THERE IS A GRAIN OF INTEGRITY LEFT IN ANY OF THEM; THE ONES WHO OPPOSE THE MEASURE SHOULD HAVE THEIR HEADS SHAVED AND 'TARRED' WITH FEATHERS !

6 Posted by MHoward at 06/12/07 07:20 PM

Dear Consumers Union

As you know the Senate has recently passed bill S.1082, commonly known as the FDA Revitalization Act. As a consumer of nutritional supplements I am concerned that this legislation, as it is currently written (please see below), opens the door for considerable regulatory confusion and will enable the FDA to undermine my access to safe and effective dietary supplements.

There must be no confusing the safety of drugs and the safety of food and food ingredients – they are different and as such governed by different laws. I am sure that Consumers Union is not intending to ignore this difference. As a consumer organization I am sure that you are interested in protecting the rights of access to nutritional supplements of the 150 million Americans who rely on dietary supplements to assist their health. Therefore I am sure you would support a simple change in the language of the bill. I am asking that this organizationactively supports the following amendment, which will not in any way stop the FDA from identifying truly contaminated foods that pose a risk to human health.

Changes in Existing Law

The following provides a print of the existing statute or part or section thereof to be amended or replaced so as to delete the words “or unreasonable” (existing law proposed to be omitted is enclosed in black brackets, existing law in which no change is proposed is shown in roman):

CHAPTER IV – FOOD

SEC. 402
(f) –

(1) If it is a dietary supplement or contains a dietary ingredient that –
(A) presents a significant [or unreasonable] risk of illness or injury under

(i) conditions of use recommended or suggested in labeling, or
(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use:

Changes in Proposed Bills

Proposed amendment to S 1082 and HR 1561:

The bills are hereby amended to prohibit the Foundation or Institute from evaluating the health benefit or efficacy of foods, dietary ingredients, and dietary supplements and to limit the review of foods, dietary ingredients and dietary supplements to a determination of whether they are safe. In assessing whether dietary ingredients and dietary supplements are safe, the Foundation or Institute shall not compare product risks with health benefits or efficacy. Instead, the Foundation or Institute shall determine whether the product presents a significant risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are recommended or suggested in labeling, under ordinary conditions of use.

Please help preserve my rights and support this amendment. Thank you.

7 Posted by Bruce Ogden MD at 06/12/07 10:28 PM

ALL drugs have potentially serious and dangerous side effects, some of which are only learned of after years of use. For example, aspirin has been used for centuries, but it wasn't until the 1980's that we learned through research that children with the flu who took aspirin were at greater risk of developing a life-threatening neurologic problem, Reyes Syndrome. Unwanted side-effects are a fact of life about all drugs and are not the result of a conspiracy against the public by the pharmaceutical and medical communities.

Before a drug is approved for use, the FDA requires that extensive research be done into the effectiveness and safety over a period of years. The FDA also mandates tracking for side effects after approval. It often takes many years of study after approval to determine accurately if a particular drug has a side effect that is due to the drug and not just to chance alone.

For example, many people who have never taken Vioxx develop heart trouble. Heart trouble is more common in older people, who are more likely to have arthritis and be taking medication for pain, such as Vioxx long term for this chronic condition. If an older person taking Vioxx daily for arthritis develops heart trouble, it's difficult to know whether the heart trouble is a side effect of the Vioxx or occurred because it would have developed if the person didn't take Vioxx.

I believe it is worthwhile for all drugs (not just new ones) to have a warning on them that they might be found to have unknown dangerous side effects in the future, to have the drug companies publish the results of all their studies (both good and bad results), and to have the drug companies be required to track side effects after drug approval. However, more legislation, bureaucracy and fees imposed on drug companies will not make this process any easier, and will make fewer life-saving drugs available at greater cost in the long run.

The person above who investigated her own medications has the right idea; each of us should take responsibility for our own health and welfare and should read the package inserts and research our own medications for potential side effects over and above the extensive work the FDA and the drug companies do.

8 Posted by Karen Reid at 06/13/07 02:19 PM

Stop letting the drug companies get away with lying about their products. We need protection from those companies only out to make a buck. Increase the penalties for companies that knowingly hide important information in order to get their product on the market.

9 Posted by TLS at 06/13/07 02:48 PM

I think that Dr. Ogden (listed below) has some very valid points.
I also think that it's very important for people to understand that the pharmaceutical companies DO track the side effects of a drug post market. These "adverse events" are then reported to the FDA on a scheduled basis. ALL drugs (prescription and over-the-counter) have side effects. In order for a drug to make it through the approval process, the benefit MUST outweigh the risk.
Also, more side effects may develop in a larger population. Clinical trials are limited to a smaller group. Once a new drug hits the market, it is available to millions of people with many different situations which may not have been present during the clinical trials. If there is a new side effect of the drug that is not listed on the package insert and it is determined to be a trend, a label revision is made.
All of the information regarding side effects, label revisions, recalls, etc. are available on the FDA website at fda.gov.

10 Posted by Dr. Allan Boodnick at 06/13/07 11:41 PM

Why must there be so much controversy for such an obvious solution to consumer protection? An informed and educated public, including doctors and pharmacists, are for the public good; withholding critical informaiton is not.

So, let's broaden the focus to include pharmaceutical greed, and ask, "When is enough money/profit, enough?" "Where are the ethics and morality of the companies that are supposed to treat pain and suffering, but are causing it (and worse), instead?

Oversight, in the form of legislation, is needed for an industry that can't and won't take responsibility for the health care it professes to deliver.

11 Posted by E Chypre at 06/15/07 08:59 AM

Almost 40 years ago a prescription my doctor gave me to stop heavy bleeding with menses caused a stroke at age 29. I took half the 'recommended' dosage, and when I got up the next morning my left side was numb, and has been for 40 years. I was never warned of the side effects - and suppose I had take the whole dosage? Ever since then I keep a Physician's Desk Reference handy and look up prescriptions before we take them. I hate to see prescription drugs advertised in magazines like corn flakes!

12 Posted by harold at 06/15/07 02:55 PM

i found out the hard way we are not to trust drs because they are after the money too
i had a stroke march 19 2004 and had i known at the time vioxx would cause a stroke, i never would have taken the drs word for it that it would not do anything other than what it was designed to do
now after 3 years i found that it is al about money which they are after, not safety or good health but cash works great in thier bank accounts, not better health as they lead us to belive and it is makinmg fools out of dignified upstanding citizens who themselves built up large bank accounts by burying thier mistakes

13 Posted by Linda at 06/15/07 04:56 PM

Greed is ruining our country and it is time if the Senate and the House won't listen to the people that we throw them all out, even the ones we like.

For the first time in my life I became sick with ulcers. My doctor ran some test and told me I had Acid Reflux and H-Pylori, but that the H-Pylori could be treated with antibiotics. However, he warned there was some specualtion the treatment could make the acid reflux worse. Since the acid reflux had never bothered me I wasn't worried about it. The antibiotics GAVE me Acid Reflux and it controls whether I can eat or drink my favorite foods. However, that was not the shocker. The shocker came the next time I was prescribed Naproxen and I developed ulcers. Come to find out, Naproxen was what caused my ulcers in the first place, not H-Pylori. Drugs ruined my life, something so simple as a pain reliver. The drug companies know about these side effects, but they want you to get sick from their drugs, so you have to buy more drugs from them to treat that problem and it creates an endless cycle. I avoid drugs at all cost now, especially anything new on the market. There are older drugs just as good, the drug companies have just lost their patent. This is all about greed and nothing else.

14 Posted by Camille at 06/15/07 05:49 PM

A friend of mine was taking Seroquel, a medicine used for bipolar disorders...

Three months ago he was diagnosed with a severe case of diabetes.

There was no history of diabetes in his family or his family's medical history.

He was awarded $400,000 in a class action suit against the people who make this drug, but that will never cure him.
He was awarded $40,000 in a class action suit against the people who make this drug, but that will never cure him.
For the rest of his life, he will have to inject himself with insulin three times a day. For the rest of his life, he will have to cope with the dangerous symptoms of this illness.

There are many people in the mental health community who are being pushed into taking Seroquel...in particular, I am thinking of another friend who is being pushed to take Seroquel, even though he already has been diagnosed with a prediabetic condition!

I do believe that people need to take responsiblity for thier health treament by doing the research before taking or continuing a medicine...however, some are too very sick to do this ...there needs to be action taken by the government to make sure the medicines that are given to us have safety regulation laws enforced.imself with insulin three times a day. For the rest of his life, he will have to cope with the dangerous symptoms of this illness.

15 Posted by Joyce at 06/16/07 11:14 AM

I have no faith in the FDA because of stories like Patrica's. Please pass this bill. Do everything nessesary to keep our nutritional suppliments available. It is the only way we Americans have to treat ourselves for real health. "Phyisian heal thy self"

16 Posted by Jana Hill at 06/28/07 03:14 PM

Seroquel, I found, is an atypical antipsychotic. I am not mentally ill. I was ,none the less, prescribed Seroquel for insomnia from obvious causes.

That's bad enough, but there's more.This wasn't the 20 to 50 mg doses that are sometimes used off label to make people shut up and sleep. It was 600mg and 600mg for over a year! The doctor presented it to me as a very mild sleep aid.

The excessive dose and the misrepresentation and the use on a normal person make me smell a big rat. What did this doctor have to gain? A lot I found out. I'm sure that close to every one who reads this knows what was really happening here.

Will this man be censured for these acts? No, there's not a chance of that. He was doing what so many other doctors do and so was operating within the generally accepted standard of care.

17 Posted by Bill at 06/29/07 08:09 AM

I totally agree with Patricia and Joyce. The FDA is supported by the drug companies and I have no faith in their decision process. I think the Fed needs to overhaul and maybe even shut down the FDA and start over with a group of COMPETANT people who will make decisions based on science and not on passing money under the table to crooked FDA officials. I seldom see input from independent groups concerning a drug, but ALWAYS see the FDA's input.

18 Posted by Brenda Small at 07/10/07 01:00 PM

Please vote for better drug safety measures that has strong accountability measures for the drug companies. There should be strong labeling on drugs that have any side effects and all of them especially it there is the least chance of dangerous and destructive side effects. But also to stop the lobbyist for big companies from being more powerful than the people of this country. Our constitution says for and by the people so when is it? Also vote on any bill that would stop the drug companies from blocking any natural nutrient formulas that we would rather use because pharmaceuticals only band aid something temporarily and doesn't get to the real problem. We were not born of drug company drugs. We were born with natural chemicals found in whole plants.