Next stop: House floor for drug safety Posted by Liz at 06/22/07 12:03 PM

So far, the House is using its best opportunity in 5 years to overhaul our drug safety system wisely...let's hope it stays that way. House committee members voted to match the Senate with an additional $225 million in industry fees for drug safety over the next 5 years. The House bill also matches the Senate in giving the FDA the authority to require follow-up safety studies and label changes.

House bill has tougher fines and tougher conflict of interest rules for advisory committees. And, no surprise here...pressure from industry/advertising pushed members to take away moraturium on drug ads that was in draft. Instead, drug companies will be fined for “false or misleading” ads, a maximum penalty of $250,000 for the first offense and $500,000 for subsequent offenses. These fines are tougher than what the Senate passed and will hopefully dissuade PhRMA from running false ads. Sorry, I can't exactly read through their "Guiding Principals on direct-to-consumer ads" with a straight face. And amendment pushed by victim-advocate Kim Witczak, that would require an 800 number on all drug ads to report adverse events to the FDA was included!

Overall, good news. One area of some concern: we hope that requirement of clinical trial reporting will not be weakened, as the Senate's was. The public should have ALL results of clinical studies, not just those cherry picked by industry.

So, this bill will go to House floor after July 4th recess, and then to conference committee. It's there that differences between the two bills will have to be worked out. We'll need to keep the pressure on to keep these stronger House reforms intact.

comments (9)

1 Posted by Wil Anderson at 06/26/07 08:59 PM

Laws are a start but people are the answer. As long as "greed rules" loop holes in laws will be found and exploited. Americans need to get back to doing what's right not just what the law requires. Most laws are so wordy they're near meaningless and full of loop holes and really a waste of time and money when people care more about $ than doing the right thing. WAKE UP AMERICA!

2 Posted by Gloria Picchetti at 06/28/07 12:17 PM

I am not satisfied with anything done during this administration. Their decisions rests with corporate benefit over individuals and/or the environment.
Drug companies have no business advertising. It only encourages the sick to think it's their magic bullet while it may not be so. Doctors get paid enough to know what is available and if it will work for us. Advertising takes money directly out of the hands of the poor patients who pay dearly for health care.
As long as we have an immoral for profit health care system in the US no one will be healthy unless they are naturally healthy or very wealthy. If you don't believe me watch, Sicko. The only country that has great health care is France.

3 Posted by Anthony Martin Dambrosi at 06/28/07 01:48 PM

It has to be a funded mandate that has public health infrastructure
to back it up. We have seen since Reagan a trend to downsizing and privatizing every aspect of our Public Institutions under the
disguise of 'limiting big government'. Without enough trained
people to do the job passing laws is less than a small step for us
who need those institutions working yesterday.

4 Posted by Edward Forsythe at 06/28/07 03:19 PM

Wasn't the provision which would have allowed the purchase of drugs from Canada deleted from the bill? The contention that Canadian drugs are or may be unsafe because their FDA counterpart is not as efficient at testing as our FDA is ridiculous. If anything the Canadians are better at protecting the consumer than we are. A provision allowing U/S. citizens to purchase drugs from Canadian pharmaceutical companies should be included.

5 Posted by Holly at 06/28/07 08:56 PM

I recommend that everyone see Money Talks: Profits Before Patient Safety which is a documentary about pharmaceutical marketing from drug reps all the way up to lobbyists. It was shocking to hear that the FDA doesn't have to report all the deaths it knows about when considering the safety of a drug because of Federal Trade Secret laws. And it was shocking to hear that new drugs are not compared to older drugs to show that they are more effective. Our drug laws are out of whack. Only the US and New Zealand even allow drug ads on television, and this to me is the biggest ill, we are being brainwashed over time to believe that pills will solve anything. Our kids are growing up with this message. We need to overhaul the whole system.

6 Posted by Joe Castronovo at 06/28/07 11:40 PM

This FDA rule will directly raise the price of dietary supplements for all consumers. The FDA acknowledges this and says “We expect that the majority of these costs will be borne by consumers of dietary supplements, who will likely respond to the increase in prices by reducing consumption.” Thus, the FDA is intentionally seeking to shrink the size of the dietary supplement industry and reduce the influence of safe and effective options to improve the dreadful trend in the health of Americans. The goal is to leave toxic drugs as the primary health option.

Independent analysis of this FDA rule has placed cost of compliance at 10 fold what the FDA estimates with as many as 50% of small companies unable to comply.

The gutless cowards of Congress, a majority of whom are on the Big Pharma payroll or will be on it once they leave Congress, have delegated their lawmaking powers granted by the U.S. Constitution to a bunch of Big Pharma-friendly unelected bureaucrats at the FDA, who are in turn using this power to undermine free commerce and help Big Pharma eliminate competition from the market. This will enrich Big Pharma even more and with the FDA now in the Pharmaceutical Business, we will pay the price.

7 Posted by Claudette Scott at 06/29/07 11:10 AM

If the feds are going to demand stricter rules on dietary supplements, then they must ALSO demand that insurance companies pay their share for them as they do on pharma products.

8 Posted by Janet Russo at 07/01/07 09:22 AM

Isn't it a shame that the people we sent to congress (with few exceptions) of both parties seem to have forgotten what we send them to congress to do. They "follow the money" instead of representing the voters. With the situation in Britain and Scotland, they should demand that we ramp up our border security, our port security, etc,NOW. But will they? NO!! They just make a few more people take off their shoes and then tell us they are doing something...I am disgusted!!

9 Posted by colechi at 10/26/07 10:36 PM

Drug companies should spend less money on ads and more finance on making their drugs less dangerous. Is it not enough that we spend hours in the Dr.'s office waiting to see the Dr. because he is being visited by the drug company's reps (pushers)? (so we, the patient, have to wait)

Health Care... I propose that we move to another label, such as Medical Financing. If this was addressed, it would change the fact that so many people think they need the drugs 'as seen on tv'. Debates on 'Health Care' should be reserved for the subject of caring for health, not Medical Financing. What we are really talking about when we are debating 'Health Care' is Medical Finance... how to pay for medical care, it is related to Finance. I'm in no way suggesting that all the debating going on under the title of Health Care be changed (please continue), but rather, the title we give to this subject should be changed.

Specifically call it what it is, how to pay for medical services. Health Care is about education and methods to better our health prior to needing Medical Finance. If the title Health Care was reserved for the discussion of our actual health, we may become a more healthy nation. Instead, we just discuss how to cover the drug and insurance companies cost (including their advertisement) and because of the title we give the discussion (health care), Health Care is misunderstood, mislabeled and in effect does not truly exist.

Labeling these issues correctly would not only open a new discussion on the very important subject of our national health, but free up discussions and debates on the issue of how to pay for medical services, drugs and insurance responsibilities we all have. Give them both the attention they deserve - they are not at all the same thing.