Some New Medicines are Approved More Quickly than Others

Joe DiMasi of the Tufts Center for the Study of Drug Development, and colleagues, have reviewed the time it takes for the FDA to review different types of new drugs.

seniors-and-prescriptionsFDA’s Neurology division, which approves drugs for Alzheimer’s disease, multiple sclerosis, Parkinson’s disease, and stroke, takes three times as long to approve drugs as the Oncology division. These differences cannot be explained by differences workload, the type and complexity of the drugs reviewed, or the safety of the drugs approved.

If the FDA could cut the performance gap between the divisions in half, the authors estimate that the cost of developing a new drug would decrease by $46 million — a savings that adds up to approximately $874 million per year.

Full report available from the Manhattan Institute.

Comments (9)

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  1. Thomas says:

    Many times this could be due to the urgency of the drug needing to be passed to reach a patient. Cancer drugs seem to often get fast tracked to approval to reach patients, especially with complex diseases and a small window of opportunity to provide treatment.

    • Matthew says:

      Could it be that oncology drugs will make a greater impact in the short run and that the drugs that take longer to approve are being tested in their efficiency?

      • Pamela says:

        You are probably spot on Matthew! If oncology drugs are more likely to make an impact in the short run, they will probably be fast-tracked.

      • Beth says:

        On your second point, I think that the drugs that take longer to approve aren’t being tested for their efficiency so much as they are being tested for all possible side-effects.

    • Buddy says:

      There should be no favoritism as to which drug gets approved before another. Initiatives should be taken to improve the FDAs drug review process.

      • Walter says:

        I agree that it shouldn’t be based on the type of ailment, but those with already more thorough research should have priority because there is more accurate information about the drug.

  2. Walter Q. says:

    Fast tracking these drugs will cut costs for the companies that develop these drugs, as their patents will have a longer life span while the drug is on the market. Much of the life of a patent gets eaten up in the approval stage.

    • Walter says:

      You are assuming that the drug is safe and won’t have any harmful side-effects. The reason the FDA takes so long in approving some drugs over others is the fact that they need to determine all of the possible side-effects of a drug before they can put it on the market. I am glad the FDA is being rather safe than sorry.

  3. Arian says:

    Oncology must be on the cutting edge of drugs to solve ailments, which is probably why its drugs are getting fast-tracked. Cancer and the others have had billions of dollars pumped into research with nothing yet to completely solve the issue. However, once cancer reaches a level where a drug is said be cure-all, then it will most likely be fast-tracked as with the case of oncology drugs.