The US Food and Drug Administration (FDA) approves a dozen of cancer drugs each year that show that they can reduce or slow down the spread of cancer in the early findings. However, fewer drugs are proved to improve the quality of life among cancer patients. The big question is how many drugs have been proved to be effective in the long run. Considering the issue, the FDA has convened the first meeting in the last 10 years to consider pulling back approvals from these cancer drugs that have not been able to show that they are effective in the long run and can improve quality of life in cancer patients. The officials have said that they have used innovative research shortcuts to increase the availability of cancer drugs for severely ill patients. However, many health experts have said that the agency has failed to zero in on medicines that do not deliver on their early findings.
It has left a glut of expensive and unverified cancer drugs in the market. A cancer specialist Dr. Ezekiel Emanuel, who is a bioethicist at the University of Pennsylvania, has said that doctors are prescribing these medicines and patients are having them without knowing all their toxic properties. He has said that people who are dealing with such a dreaded disease should not be put into a situation of uncertainty. The FDA officials have said that an unprecedented level of drug development has prompted an industry-wide review of these cancer drugs. The agency has chaired a three-day meeting of drugs from Merck, Roche, and Bristol-Myers Squibb that is part of this industry-wide review.
The agency has held such kinds of meeting only three times in its history. The last meeting has been held in 2011. As per the report, the US is the only country in the world that spends huge money on per person prescription drugs. The data from the IQVIA have shown that the spending on cancer drugs has increased more than double since 2013 in the US that is more than $60 billion per year. Health experts have said that new drugs normally cost around $90000 to $300000 per year. The prices of these drugs have increased much faster than the survival of the patients. The FDA will not consider the cost of these drugs but the agency is all set to keep a wide range of drugs ineffective drugs off the market. Some cancer specialists from the University of California have said that the agency is going to act like a small court that will decide whether people can do better without some more expensive and ineffective drugs.
The agency will be hearing presentations from the drug developers and seek guidance from a panel of cancer experts to reach a conclusion. The officials have said these discussions are important, as a failed study does not show that the drug is unproductive. The agency is yet to make a final decision on pulling out approvals from some ineffective medicines but it seems certain that the agency is up for some tough measures this time. Since last year, four drugmakers have voluntarily requested deletion of approvals for many types of their lung and bladder cancer drugs. Each drug has shown great results in the early findings but has failed to increase the survival rate in patients.
Several former directors of the FDA have lauded the removal of four cancer drug approvals. They have said that the move shows that the accelerated approval program of the agency is healthy. However, they have said that the removal of such approvals should be this rare. Congress has given the FDA the authority to speed up the approval of the drugs based on the early findings of the study in 1992. This decision has come after many HIV patients and activists have been protesting over the slow speed of drug development. This move has given a cheaper and faster path to industries to introduce their drugs in the market. Under this faster approval program, ideally, drugs that are not able to help patients or provide a better quality of life in the long run, their approvals will stand canceled. However, that has rarely happened in the US. As per the report, out of 155 accelerated drug approvals, only 10 have been withdrawn so far and all of these approval cancellations have voluntarily come from the drugmakers. The FDA has used its power to cancel an expedited approval of a cancer drug just once. The agency has taken more than a year to finally revoke the approval of Roche’s much-hyped breast cancer drug called Avastin. On the other hand, the company has been flooded by the calls from patients and libertarian groups to keep the approval despite evident data that have shown that the drug is not able to increase the survival rate in patients. Now, the agency is going to review Merck’s Keytruda, Roche’s Tecentriq, and Bristol Mayers Squibb’s Opdivo.
These drugs have been creating a wave of immunotherapies that help the body’s immune system to detect and attack cancer cells. However, initial studies by these three companies have shown negative or uncertain results. These drugs have many dozen approvals in indications such as forms of bladder, throat, and liver cancer that are the key points; the agency will be looking at. As per the data, these drugs have shown life-extending benefits against deadly types of skin and lung cancer. Experts have said that even if all six uses of these drugs that are under review are revoked, the drugs will be in the market as they are authorized for many other indications. Health experts have said that expedited approvals are meant for drugs that are for unmet needs. However, these days, nearly a third of all cancer drugs are reaching the market through this easy path. Some drugs that are for overlapping uses as well are approved through this channel.
