Opinion: Improving FDA Evaluations Without Jeopardizing Safety and Efficacy

What can be done to lower development costs and drug prices?

Written byJohn D. Loike and Jennifer Miller
| 4 min read

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Drug approvals by the US Food and Drug Administration (FDA) dropped dramatically in 2016—down by 57 percent over the year before. While some of this decline was due to a record number of approvals in 2015, only 22 novel drugs were approved last year—fewer than in each of the previous five years. Striving to make returns on their investments—to gain FDA approval for a novel therapy averages around $2.6 billion and 10 years—pharmaceutical companies sometimes hike drug prices to offset low productivity. Prescription drugs are the fastest growing health-care expense, with costs increasing by 9 percent from 2014 to 2015, according to the latest report from the Centers for Medicare & Medicaid Services (CMS).

In addition to translating to high medication prices for patients, the ...

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Meet the Author

  • John Loike

    John Loike serves as the interim director of bioethics at New York Medical College and as a professor of biology at Touro University. He served previously as the codirector for graduate studies in the Department of Physiology Cellular Biophysics and director of Special Programs in the Center for Bioethics at Columbia University College of Physicians and Surgeons. His biomedical research focuses on how human white blood cells combat infections and cancer. Loike lectures internationally on emerging topics in bioethics, organizes international conferences, and has published more than 150 papers and abstracts in the areas of immunology, cancer, and bioethics. He earned his Ph.D. from the Albert Einstein College of Medicine of Yeshiva University.

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Published In

March 2017

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