Even though implication sounds logical I am not sure how not spending/redirecting expenditures on marketing (and lobbyist) would really influence drug prices since sales are on revenue generation side (DTC is a bane IMO but ROI is significant I hear) with connection to price nebulus to me. I have experienced revenues down resulting in reducing R&D spend and layoffs in Manufacturing which may not be linked to prices either but effects long term viability.

Don’t you think that if PHARMA stopped spending up to $57 billing in marketing
of which $4.8 billion is spent on direct to consumer ads, plus $2.7 billion
by their lobbyists on member of congress, the price of USA made drugs would
not rise?

My career goes beyond 20 years and my experience goes back to the 60s.

Sam I do think PHARMA (like most industries) has slipped from a prevailing attitude to make best and safest product possible if your label is affixed, even if acquired components from overseas (which think has been done for many years although concentration in Far East accelerated in past 20 years). I am in favor of keeping US based manufacturing jobs and lessening burden on FDA inspectors but realities of differential burden costs I do not see willingness of consumers to bear the higher cost it would demand.

In those days, professional journals for pharmacists would note FDA citations
for various manufacturers whose product(s() or plant operations were substandard of FDA criteria. In some cases manufacturing plants were closed until standards of the FDA were met.

If PHARMA was not always compliant with FDA standards before - for what
ever reason (human error, equipment breakdown, etc) how can we make them
completely responsible for the quality of our drugs? We always talk about
over sight committees to ensure quality of product or the waste of money,
therefore the FDA must take an active roll for this responsibility.

Quality assurance is always talked about when people’s lives are concerned whether it be in a hospitals, the food we eat or the cars that we drive. I
would like to to see the import of raw drugs eliminated; give the American
workers jobs and eliminate the need for FDA agents flying to other countries.

As I’ve said elsewhere, there are numerous other ways to accomplish lawsuit reform, which I think has merits, besides what I view as this “nuclear option” - total destruction. As you will know, some of that has happened already - limits on punitive damages, class action suits, and so on.

I guess it helps not to be a lawyer! If/when “academic reform” happens, I may sound differently!

Why should the pharmaceutical industry have it any better? They are a business just like any other.
If they are sold a bogus excipient, it is the pharmaceutical company’s responsibility to recoup their losses from that supplier. It is not the tax payer’s responsibility.

Insist on fines large enough to make it more cost effective to instill more precautionary systems. Release the lessor product information to the media IMMEDIATELY, and do not allow them to pass the buck. Humiliation is a wonderful deterent.

It is their responsibility to produce their products just as they were when they applied for and gained approval. (The FDA would do good to remember that themselves)

Tossing more money at this protective body is not going to resolve the issue.

Without trying to debate the matter, I will say that we know of only one case, Benedectin for morning sickness, where it appears that lawsuits ended up taking a drug off the market that did not have the risks claimed. That is why preemptors, if you listen to them, constantly invoke it as an example. There simply do not appear to be others.

So I would suggest that may be relevant, along with the well known cases and their outcomes. Along with asking: On balance, how much that was “frivolous” do you really see - both in claims and in results? The “frivolous lawsuit” may have as much reality, in the end, as “evil pharma.” Both ways we demonize without taking the time to analyze.

Finally, there is the difficult cost/benefit analysis of what we _lose_ by taking civil liability out of the picture. We invoke, and rightfully should, rights for _legitimate_ compensation, the issue of accountability, safety data otherwise unrevealed, and so on.

Does the argument for making FDA the sole arbiter really counter-balance all of these? That is the question.

Frivolous lawsuits raise the price of medications for everyone, clog the court system, and reduce profits. Valid lawsuits help ensure companies act responsibly. I see good and bad to both.

But lots of things have an upside and a downside. I could wear a seat-belt or not wear a seat-belt. In some types of accidents wearing a seat-belt reduces the risk of injury. In other types of accidents, wearing a seat-belt increases your risk of an injury. But the relative risks are no where close to equal - quite simply I’m much more likely to suffer an accident where wearing a seat-belt will help me than hurt me.

We have no idea how much frivolous there are, and how much they cost. We have no idea how much more irresponsibly companies would act if preemption protected them from lawsuits.

So how can I figure out which system is better?

I don’t know a whole lot about how the justice system works. Will we ever get close to fairly guestimating either of those numbers?