U.S. regulators and the drug industry want to extend by two months the deadline for the Food and Drug Administration to approve or reject new drugs. The FDA said it would need an extra 60-day “filing date” before the clock starts ticking on its 10-month deadline to review new drugs, or six months for a priority review. This means even less time on the market to recoup costs and is one of the reasons why new drug prices are going to continue to climb.
For those of you who are not familiar the clock on patent expiration for drugs can start many years before the drug is approved by the FDA and make it to market. Now some of you probably are saying “good, it means lower cost drugs” but in reality it means higher priced new drugs and less money for new drug development.
Everyone keeps complaining about the prices of new drugs but in reality prescription drugs only account for 10% of every healthcare dollar spent in this country. The real culprit of rising healthcare costs are consumers who don’ take responsibility for a healthy lifestyle and the fact that insurers love to make lots of money to woo investors.
Now that the FDA is often sending drug companies back for more clinical studies before approving drugs the industry as a whole needs to look at exactly when the clock is going to start ticking for patent expiration. This author feels that the clock should start ticking when drugs are approved thus allowing drug companies to do every necessary clinical trial without rushing to get the product approved. By having a change in the ROI model it could lead to lower drug costs as drug companies are going to have more time to recoup development costs.
Oh, for those of you feel that the drug industry should not make money I suggest you take a basic business course to learn what the word capitalism is about. Almost every drug company has a program where patients can get drugs at greatly reduced costs and so far they have given away billions of dollars in free drugs to patients.