{"id":141798,"date":"2010-01-05T16:39:05","date_gmt":"2010-01-05T21:39:05","guid":{"rendered":"http:\/\/blogs.wsj.com\/health\/2010\/01\/05\/fda-drug-approvals-in-2009-up-a-little-from-2008\/"},"modified":"2010-01-05T16:39:05","modified_gmt":"2010-01-05T21:39:05","slug":"fda-drug-approvals-in-2009-up-a-little-from-2008","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/141798","title":{"rendered":"FDA Drug Approvals in 2009: Up (a Little) from 2008"},"content":{"rendered":"

\"Pill\"Last year saw big changes at the FDA — starting at the top with a new commissioner<\/a>, appointed by a new administration — but you wouldn’t know it from looking at the number of drugs the agency approved.<\/p>\n

The Obama-era FDA approved 26 new drugs last year. That’s a hair’s breadth from the 25 new drugs approved by the Bush-era FDA in 2008, according to figures out today from Washington Analysis, a research shop whose customers are institutional investors.<\/p>\n

Of course, the drug approval process is a long one, and changes put in place last year may take a while to play out. Ira Loss, a senior health policy analyst at Washington Analysis, suggested that a recent increase in funding for the agency could speed up the decision-making process. <\/p>\n

Companies “are going to have a better experience trying to get to the end of the line,” Loss told us when we got him on the phone this afternoon. “Better funding of the agency is going to mean that there are fewer delays.”<\/p>\n

The FDA approved seven biotech drugs and 19 traditional (i.e. small molecule) drugs last year. While the number of small-molecule drugs approved was comparable to the figures from recent years, the number of biotech drug approvals was up from two in 2007 and four in 2008.<\/p>\n

If we were in an expansive mood, we might suggest that the increase reflects big pharma’s big push into biotech. But maybe the numbers are just a blip. After we got off the phone with Loss, we emailed him to ask what he thought. Here’s his reply: <\/p>\n

\n

I think it has the potential to be a breakout, but I am not prepared to say so based on one year. If there is a repeat performance in 2010 then I would be prepared to say the long awaited breakthrough in therapeutic biotech approvals may in fact be here. But not yet!<\/p>\n<\/blockquote>\n

The FDA expects to report its number of 2009 drug approvals by Friday, but the agency reported 25 new drugs approved as of Dec. 1, according to the Associated Press<\/a>. You can search the FDA\u0092s reports on drug approvals here<\/a>. <\/p>\n

Bonus Approval<\/strong>: Take a walk through 2009 with the Health Blog. Read our posts on some of last year’s new drugs: Multaq<\/a> from Sanofi-Aventis, Effient<\/a> from Eli Lilly and Daiichi Sankyo, Simponi<\/a> from J&J and Onglyza<\/a> from Bristol-Myers Squibb and AstraZeneca. For more on some of last year’s key approvals (and delays), see this story from Dow Jones Newswires<\/a>.<\/p>\n

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<\/p>\n","protected":false},"excerpt":{"rendered":"

Last year saw big changes at the FDA — starting at the top with a new commissioner, appointed by a new administration — but you wouldn’t know it from looking at the number of drugs the agency approved. The Obama-era FDA approved 26 new drugs last year. That’s a hair’s breadth from the 25 new […]<\/p>\n","protected":false},"author":650,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-141798","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/141798","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/users\/650"}],"replies":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/comments?post=141798"}],"version-history":[{"count":0,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/141798\/revisions"}],"wp:attachment":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/media?parent=141798"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/categories?post=141798"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/tags?post=141798"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}