Food and Drug Administration Approves 45 New Drugs in 2015; Many Are Very Costly

Last year, first-of-a-kind drug approvals by the FDA reached their highest level in 19 years. The annual total of first-of-a-kind drugs increased to this level because of the drug industry’s focus on drugs designed to treat rare and hard-to-treat diseases. In 2015, the Food and Drug Administration (FDA) approved 45 drugs with never-before-sold ingredients.

The FDA’s approvals are considered innovative in the treatment of rare and hard-to-treat diseases. This should be considered big news for the pharmaceutical companies as well as patients. However, specialty drugs on the market are accompanied by controversy over the enormous increase in drug costs to patients.

In fact, one of the most expensive drugs of the year was produced by Vertex Pharmaceuticals. The drug, Orkambi, is appropriate for treatment of cystic fibrosis. It is one of the most expensive drugs on the market and sells for $259,000 per year. The drug has been proven to iincrease lung function in patients with the deadly inherited lung disease. Cystic fibrosis is a disease that causes the buildup of sticky mucus to develop throughout the body.

Another very expensive drug is Ibrance, a breast cancer drug developed by the pharmaceutical company, Pfizer. The cost of Ibrance is $118,200 per year. This drug, like many other cancer drugs, is very expensive.

Another expensive drug, this one produced by Bristol-Meyers Squibb, is the hepatitis C pill, Daklinza, which costs $63,000 for a 12-week supply.

According to an Associated Press article, between 2007 and 2011, only one of 19 drugs entering early-stage testing actually reached the marketplace. Today, 1 in 13 early-stage drugs enter the market.

In spite of these newly developed drugs, the time it takes to discover and develop a new drug has been getting longer and is now more than 14 years. It used to be that any drug might take as long as 10 years to reach the marketplace. The longer time in development is driven by the growing complexity of drug trials and demands for more data from drug insurers.

It has been predicted that 225 new drugs will be approved worldwide between 2016 and 2020. Interestingly enough, the report from the Associated Press included a comment that smaller pharmaceutical companies seem to have lower research and development costs and higher sales per product compared to the large pharmaceutical companies. With new and improved drugs to combat deadly diseases, the hopes are that the prices will decrease dramatically and that the results will cure or lengthen the lives of Americans in need of these important medicines.

Kreisman Law Offices has been handling product liability cases, pharmaceutical liability cases, dietary supplement cases and catastrophic injury cases for individuals and families who have been injured or killed by the negligence of another for more than 40 years, in and around Chicago, Cook County and its surrounding areas including, Vernon Hills, Wheeling, Waukegan, Inverness, Long Grove, Libertyville, Rosemont, Warrenville, Bridgeview, Maywood, Riverdale, Hinsdale, New Lenox, Wheaton, Aurora, Chicago (Jackson Park, Lincoln Square, Jefferson Park, Rogers Park, Bronzeville, Hegewisch, East Side) Palatine and Naperville, Ill.

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