Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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2015 Was Another Good Year for Orphan Drugs & Pharma Marketers

2015 Was Another Good Year for Orphan Drugs & Pharma Marketers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

UPDATED 4 Jan 2016: FDA approved 45 new drugs in 2015, four more than in 2014 and the highest number since 1996. Twenty (20) of those (43%) were "orphan" drugs. This compares to 17 orphan drugs approved in 2014 or 41% of the total (see CDER New Drug Review: 2015 Update and "2014 Was a Good Year for FDA & Pharma").


That's good news for the pharma industry, which often submit drugs to the FDA as orphan drugs but once approved the drugs are "used broadly off-label with the lucrative orphan drug protections and exclusivity benefits," according to the authors of a study recently published in the American Journal of Clinical Oncology (read "#Pharma Welfare: 'Orphan' Blockbuster Drugs on Rise - Including Crestor!"). 

Pharma marketers also have good news regarding FDA marketing enforcement actions in 2015.


More about that here.

Pharma Guy's insight:

Meanwhile, FDA is slow to approve generic drugs, which helps boost drug prices; see http://sco.lt/5mHdZ3 

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The Dog - i.e., RA Contractor - Ate Our Adverse Event Data. FDA Doesn't Buy the Excuse, Sends Letter

Blame it on the contractor.


That’s the reason Heritage Pharmaceuticals gave the Food and Drug Administration after an agency inspector found 10 instances in which the generic drug maker failed to convey side effect reports about its medicines, which is required by law.


Between 2010 and 2014, the company did not submit an unspecified number of side effect reports concerning an undisclosed number of its drugs, according to a Nov. 5 warning letter that the agency sent to the drug maker.


Such violations are rare.


Whenever a drug maker receives a side effect report about one of its medicines, the information is supposed to be conveyed periodically to the FDA. This is standard procedure, but one that is taken seriously by regulators, since they must detect troubling trends with drugs.


By and large, drug makers are keen to comply with this requirement. Not only do companies fear the wrath of FDA officials, they want to avoid the suggestion they are unwilling to disclose side effects. In fact, only once during the past four years has a company not filed required reports, according to the FDA database. And there have only been eight other instances during the past decade.


But in its annual reports filed with the agency between 2010 and 2014, Heritage noted that there were no side effect reports. Yet, an agency inspector found at least 10 such instances. So what was the problem? When confronted with the discrepancy, Heritage blamed a regulatory affairs contractor for the failure, according to the warning letter.

Pharma Guy's insight:

Gee, I wonder who the contractor was?

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