News Feature | October 7, 2014

New Report Reveals FDA-Approved New Molecular Entities: 1827-2013

By Cyndi Root

A new report was recently published on Drug Discovery Today highlighting the  Food and Drug Administration’s history of New Molecular Entity (NME) approvals from 1827-2013. The authors of the study state that, as of 2013, the FDA has approved 1,453 drugs, not counting generic versions. According to Regulatory Affairs Professional Society (RAPS), which released a feature on the report, there was a decrease in the number of companies with approved NMEs, which it attributes to increasing mergers and acquisitions.

While Pfizer leads the pack with 198 NMEs, the majority of NMEs are sponsored by small companies. Forecasting the future, the paper’s authors state, "The first decade of the new millennium witnessed the highest levels of volatility thus far (118 entries offset by 124 exits) and these trends are likely to continue based on information from the early part of the current decade (2011–2013).”

FDA NME Approvals

The paper titled, "An Overview of FDA-Approved New Molecular Entities (NMEs): 1827-2013," was authored by Michael S. Kinch, Austin Haynesworth, Sarah L. Kinch, and Denton Hoyer. RAPS states that the research was an “ambitious attempt” as it set out to analyze the FDA and its predecessor agencies — despite the fact the FDA’s website and its “Orange Book” gave an incomplete picture due to the number of drugs withdrawn from the market.

The researchers found that despite the approval of Merck’s morphine in 1827 and aspirin in 1899, the modern pharmaceutical industry did not begin until the 1930s. The number of NME approvals averaged about four per year until 1950. Authors state, “Thereafter, the FDA began to regularly approve in excess of 10 NMEs each year until the 1980s, when it began to regularly approve more than 20 NMEs each year. Its approval rate peaked in 1997, when the agency approved a whopping 55 NMEs — a number the agency has never again come close to matching.”

Unique Companies

The RAPS report on the study points out an issue that received far less attention than approved NMEs. From 1930 to 1945, less than 20 companies had drugs approved for sale in the U.S. By the 1980s, about 60 companies marketed approved drugs. While around 90 companies have approved NMEs now, this is actually a decline in unique companies, which RAPs says is due to drugs being withdrawn, companies exiting the market, and companies repositioning through mergers and acquisitions.