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Regulatory News | 03 October 2014 | By Alexander Gaffney, RAC
Pop quiz: While the US Food and Drug Administration (FDA) approves dozens of drugs each year, how many new drugs—i.e. discounting generic versions of approved drugs—has it approved in its entire existence?
Until recently, the answer to that question wasn't easy to find. You couldn't find the answer on FDA's website, and even digging into FDA's so-called "Orange Book," which contains a list of all approved drugs and their generic equivalents, wouldn't give you a complete tally since withdrawn or no-longer-marketed drugs aren't included.
But the question was of interest to Michael Kinch, Austin Haynesworth, Sarah Kinch and Denton Hoyer, the authors of a new paper recently published in Drug Discovery Today. Their paper, "An Overview of FDA-Approved New Molecular Entities (NMEs): 1827-2013," is an ambitious attempt to tally up all products approved by FDA and its numerous predecessor agencies since its inception.
The researchers determined that 1,453 drugs have obtained FDA approval as of 31 December 2013. Just a small handful of drugs received approval prior to the creation of the modern FDA in 1938, including Merck's morphine in 1827 and aspirin in 1899.
"The modern pharmaceutical industry began in earnest during the 1930s," the authors note. "The rate of NME approvals of this nascent industry remained at a relatively low level (averaging fewer than four NMEs per year) until 1950." Thereafter, 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.
But the paper also takes a look at something which receives far less attention in drug development: Unique companies with approved NMEs. In the 1930s through 1945, fewer than 20 companies had drugs approved for sale in the US. As early as 1980, fewer than 60 companies did. Though more than 90 companies now have approved NMEs, there has been a decrease in the number of companies with approved NMEs in recent years due to a large number of mergers, acquisitions, repositioning and market exits, Kinch found.
"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)," Kinch and his co-authors wrote.
The paper also looks at the companies whose NMEs were approved by FDA. Merck holds the record for the most NMEs granted in FDA history (63), with Roche, Johnson & Johnson and Eli Lilly in close contention for second place. However, one company is a clear leader in the number of approved NMEs now controlled. American pharmaceutical giant Pfizer owned 198 NMEs as of 2013—roughly twice its nearest competitors, Merck (106) and Novartis (98).
The overwhelming majority of NMEs, however, are still brought to market and owned by small companies, the paper found. More than 150 drugs have been brought to market as a company's sole NME, and more than 50 of these drugs remain on the market, the paper found.
Tags: FDA NME Approvals, New Molecular Entities, Drug Approvals, FDA Drug Approvals