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Friday, November 9, 2012

Obamacare requires physician samples requests be tracked

Did you know that Section 6004 of the Affordable Care Act has created a new requirement that all drug manufacturers must follow? They need to track orders of pharmaceutical samples by physician and submit specific information such as trade name dosage, package size request, package orders requested versus received, and more, to the FDA annually. The timeline to submit was pushed back to 10-1-2012 due to changing of format required for the data submission.

According to the FDA The Affordable Care Act explicitly states that manufacturers and authorized distributors must submit the following information concerning drug sample distribution to FDA: (1) the identity and quantity of drug samples requested; (2) the identity and quantity of drug samples distributed; (3) the name, address, professional designation, and signature of any person who makes or signs for the request, and (4) any other category of information determined appropriate by the Secretary.


Have you received a RX sample from your physician?

Do you think physicians will start tracking who they give samples out to? Do you think they will tell the patients they are being tracked?

Does anyone know what this information is going to be used for?

If free samples are going to be a thing of the past, there will definitely be an increase in the cost of care, especially when trying a new pharmaceutical that may have a negative affect.

Here is more info:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm


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