Patents protect drugs from copycat versions for 20 years after the drug is invented. This is a bitter pill for pharma companies because it can take eight years or more after invention to accumulate enough data to get a drug past the U.S. Food and Drug Administration. Once the patent expires, 80% of the brand name sales can vanish within a year as generic competitors reach the market.
The majority of FDA approved drugs have serious potential side effects that are not detected before marketing approval according to “Preventing adverse drug reactions in the general population” Manag Care Interface. 2005 Oct;18(10):49-52. Obviously it is in the drug companies best interests to get drugs approved as soon as possible to start to recoup the $1 billion development costs. If the FDA requires more clinical studies to ensure the efficacy of the drug outweigh the risks than the pricing has to be adjusted to ensure maximum ROI. This means higher costs for healthcare and patients.
The other issue that the FDA and Congress need to manage is litigation against the drug industry. Lawyers should not be allowed to sue a drug company unless there is clear evidence that the drug company attempted to hide or minimize drug side effects from the public. If you were taking a drug for a serious medical condition and you found out 5 years later that this drug could cause tremors, for example, but that this was listed as a side effect on the label patients along with their physicians should have the right to weigh the risk.
Drug safety is the reason that the FDA approves drugs. However as drug therapies become more complicated and the FDA requires more clinical trials to ensure safety drug companies need to know that the clock is not ticking against them. The reward will be safer drugs with lower prices and of course less work for litigators.
Related articles
- Why drug patent protection needs to be extended (worldofdtcmarketing.com)
- Drug Patent Expirations for Dec 11 2011 (biotechblog.com)
- 27 Hot Drugs Facing FDA Approval in 2012 (thestreet.com)
- Op-Ed Contributor: Free the F.D.A. (nytimes.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.
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Rich,
Not quite sure why you are suggesting that patent protection be decreased to 12 to 15 years from the current 20 years. It seems counter intuitive to your argument that cost increases because pharma’s have to get new drug to market as quickly as possible, ie. before patents expire and generics take all of their market share? Did I miss a key point here?
Great blog!
Thanks,
Ken
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Great post Rich!
I have brought up the patent timing issue over the years & Pharma has chosen not to press the issue of patent timing. An option that would increase R&D investment & improve ROI is to start the patent clock the day that the FDA grants approval for the first indication. This would allow the pharma to complete the clinical & economic studies that would address the emerging standards without commercial penalty. Subsequent meaningful indications would be granted 20 years post FDA approval. The commercial life should not be less that 20 years from approval. The reason being that multiple studies have confirmed that adoption rates are 15+ years for new medicines.
Current IP rules are based on a data poor health industry that has horrible transparency! Within a decade this will no longer be the case! The IP rules will need to be revisited once the healthcare industry matures into a HEALTHCARE SYSTEM. Pharma & all other suppliers of healthcare solutions will be at the mercy of the indisputable real time data that payers & providers will have at their fingertips in real time to determine where REAL value is delivered in the system. It will require everyone to rewrite the current rules of commercialization!
Happy Holidays!
@pjmachado
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