The headlines in today’s Forbes magazine online says it all “How Big Pharma Undermined Medical Innovation for Financial Gain” but it is very biased and shows a lack of working knowledge of the drug industry. Let me try and respond to some key points.
The article’s main thesis is big pharma is trying to stifle biotech “fast track” approval of drugs because it benefits big pharma’s financial models”. That just doesn’t hold water. First let’s remember that Phase II trials are usually small patient populations and as thus a drugs side effects may not be able to be quantified. So what would happen if a drug was given approval in Phase II and then later on some additional new side effects came to light or that the benefits of the smaler patient population did not translate into larger patient populations ?
Then there are consumers and patient advocacy groups. What do you think would happen if a drug, that had been approval in Phase II, was later found to cause some real nasty side effects ? How long before the legal profession would start running commercials for class action litigation against drug companies that gained approval based on Phase II trials ? I have already seen commercials for lawyers who are recruiting people for a lawsuit against BI for Pradaxa.
Right now there are two major issues when it comes to getting drugs approved by the FDA: how do we ensure that the drugs they approve are safe and effective and do new drugs show true benefits to patients as compared to current treatments.
The real solution is what this BLOGGER has suggested all along: grand patent protection once a drug is approved by the FDA not when it is still in development. This would ensure that the drug industry conducts all the studies needed to ensure that our drugs are safe and effective.
If in fact a drug in development shows significant promise in patients during Phase II trials than the FDA has to evaluate the drug to determine the risk vs. the benefits to patients vs current treatments.
Related articles
- New Drugs Cost Even More Than You Think (seekerblog.com)
- How Big Pharma Undermined Medical Innovation for Financial Gain – Forbes (forbes.com)
- Want more new drugs ? Extend patent protection (worldofdtcmarketing.com)
- If the FDA wants to make prescription drugs safer than change patent protection timing (worldofdtcmarketing.com)
- Bad journalism paints unfair picture of pharma industry (worldofdtcmarketing.com)
Passionate healthcare marketer with over 10 years of experience I believe that what's best for patients is best for healthcare marketers. I also write a monthly DTC Column for PM 360 Magazine and have written many articles on healthcare marketing in an age of empowered patients.
Rich, I couldn’t agree with you more. Granting FDA approval after the equivalent of Phase II trials is ridiculous. The Phase I and Phase II trials are meant to establish who and what should be tested in the Phase III trials; there is a reason Phase IIIs are called pivotal studies.
However, I do respectfully disagree on your suggestion of not granting patents until FDA approval. Drug developers spend a lot of money just to get a new drug idea even to the point of receiving an IND designation and beginning human trials. I can understand why they’d want to make sure the IP of that investment is protected that early. And by waiting to award patents until FDA approval, you’re encouraging drug manufacturers to cut corners on cost and time to get to the finish line as quickly as possible. That does not do justice to the patients in the clinical trials.
Thanks Joshua: By granting patent protection at approval drug companies are not going to be in a rush to cut corners they will do what they need to do without the clock ticking so I disagree with your statement
What about a preliminary research patent of x years for appropriate clinical trials, followed up by a marketing lifetime patent of y years?
You may be right. But if a company has no patent protection for their product, they’ll be in a race against any potential competitors to get their idea to approval first so they get the patent.
I like Tristan’s idea of a sort of preliminary patent, valid only for the amount of time needed to complete clinical trials. You could even make it conditional on the clinical program continuing to make steady progress; if more than X months elapse without clinical activity being reported or a NDA being filed, the patent is automatically rescinded.
I agree 100% with Richards.
In fact now a days it has become a fasion with journalist’s & magazine to piblish articles without knowledge of the basics and nitty-gritty of the subject. Their objective is to create sensation by resorting to yellow journalism for increasing sales of their magazine.