The FDA Approved How Many New Drugs?
17 CommentsBy Ed Silverman // November 3rd, 2011 // 11:27 am
Why not take an opportunity to crow when the numbers are going your way? That is what the FDA is doing today with a new report that trumpets that 35 new medicines were approved over the past 12 months, which is nearly the highest number of approvals in the past decade. The only year in which the agency issued more approvals was in 2009, when there were 37 such endorsements.
The FDA also boasts that approval times are faster than elsewhere - 24 of the 35 newly approved drugs occurred in the US before any other country in the world and also before the European Union. “Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients,” says FDA commish Margaret Hamburg in a statement.
The report was, of course, released to counter critics who say the FDA is out of step with the needs of the public - and drug makers, too. Ever since the Vioxx scandal raised safety concerns, the agency has been criticized for pushing the pendulum too far in the other direction, a shift that some say was accelerated after Hamburg was named commissioner.
To rebut the naysayers, the agency tried to make a splash today by not only releasing the report, but also holding a media briefing to review the results. And the results are neatly packaged to contain bullet points that underscore not only the number, but the type of accomplishments involving drug approvals. Here are a few…
Of the 35 approvals, two are “breakthroughs” in personalized medicine that were approved with a diagnostic test; seven provide major advances in cancer treatment, according to the agency; 10 are for orphan diseases; 16 were approved under priority review; two-thirds were completed in a single review cycle; three were approved under accelerated approval, and 34 were approved on or before the agreed-upon review time targets, including three cancer drugs approved in less than six months (you can read the complete report here).
Greg Pawelski
In cancer medicine, the new paradigm of establishing a requirement of a companion diagnostic as a condition for approval of new targeted therapies. This new area of pharmacogenomics was ripe for proprietary tests, invented alongside the drug and owned by the drug developer and/or a partner in the diagnostics field.
It has put such great pressure that the companion diagnostics that were approved often are mostly or totally ineffective at identifying clinical responders to the various therapies. That is because genomics are far too limited in scope to encompass the vagaries and complexities of human cancer biology.
Top pharmaceutical firms specializing along disease management lines: in-licensing or co-marketing portfolios of personalized, smaller-market drugs as a package deal to physician specialties, along with a test or two.
Drug and diagnostic companies working together, with drug targets perhaps based on a diagnostic marker - not the other way around - could grease the wheels for personalized medicine.
And yet, there is a whole lot of trial-and-error treatment still going on!
Angry Pharm.D
in brief:
33 of the 35 drugs will be for rare indications that nobody ever heard of.
JH3
Well, of the listed drugs, two are protease inhibitors for hepatitis C, plus there is one for Hodgkin’s disease, one for lupus and one for prostate cancer.
That seems like five that are not for “rare” indications.
original industry insider
There is also an increasing number of Refuse to File letters from FDA, as reported here in April, indicating an overall decline in the quality of the submissions.
http://www.pharmalot.com/2011/04/why-the-fda-issues-more-refuse-to-file-letters/
Angry Pharm.D
with the exception of prostate cancer, those conditions are all rare last I checked….
Kim Kardashian
Over 3% (~200 million) of the world is infected with HCV which leads to liver disease/cancer.
How’s that orphan/rare?
JH3
An analysis by someone who knows far more about pharma than I ever will says that 10 of those 35 drugs really could be categorized as for rare indications.
Angry Pharm.D
I’m talking about use in the United States.
The FDA only approves drugs in for the USA and that’s all I was referring to…. not worldwide use or use in Central Africa.
original industry insider
Kim, make sure they rub a full panel for STD’s on you while they’re at it.
original industry insider
Why bother approving drugs in the EU anyway? By this time next year most people living in the 17 counties in the EU won’t be able to afford them anyway. Seriously, just as econonists are starting to delink the US economic recovery from the disaster that is the EU, so too maybe the FDA is pulling away as well. Another possible reason for the divergence is that EU approvals are increasingly being delayed by pricing issues, which we in the price gouging US pharmaceutical industry needn’t trifle with as much.
Nit Picker
OII,
Your 5:36pm piece refers to “Rub”. Is that a Freudian slip? I think you meant ‘run’.
Your 5:47pm piece refers to “17 counties”. I’ll bet you meant ‘countries’.
original industry insider
Sorry for the tyypos, Nit. You are vorrect.
Biotech Observer
Angry Pharm.D,
Blood clot (Pradaxa, Xarelto), Type 2 Diabetes (Tradjenta), High Blood Pressure (Edarbi), COPD (Daliresp, Arcapta Neohaler), ACS (Brilinta) are rare disease now?
Nick
OII…not being pedantic, but there are 27 countries in the EU, but 17 in the Eurozone (i.e. they use the Euro as currency). Also, pricing is not considered by EMA when approving drugs, so that will not holding up approval. Delays are more likely due to conservative nature of EMA and increasing EU Commission scrutiny. Pricing is considered on a national (not EU-wide) basis by agencies in each of the individual countries (e.g. NICE in UK). Confused yet?
original industry insider
Thanks, Nick. I better exit this thread before I lose my credibility altogether.
Nit Picker
OII
No problem but you goofed again. It should be ‘tiepoze’ and ‘cowreckt’. I don’t think they learned ya any good at grammer skool.
original industry insider
Nit, thanks again. At least I’m not a “looser”, as many people are called these days.