Great work Maryanne!

Good morning dear friends,

@Bryan Rosen whtat's up!

In regards 200229, could you please let me know  GENERAL WARM, SPECIFIC WARM?

Thank you in advance.

This set a dangerous precedent. Why is FDA able to hide behind Trade Secrets for statins but not other drugs? I assume FOIA isn’t helpful here, but what about a wrongful death suit or a malpractice suit? So many people take statins it seems the public’s need to know is paramount. 

It occurred to me: 
“If a trade secret holder fails to maintain secrecy or if the information is independently discovered, becomes released or otherwise becomes generally known, protection as a trade secret is lost. “ https://www.uspto.gov/ip-policy/trade-secret-policy  All you need is a leaker and the trade secret status is gone. 

I’ve done some work looking at WTO agreements and thought there might be a way into the data via TRIPS. 

Internationally, the rules seem to hold except in cases where the public good overrides the competitive advantage. Given how many people take statins this seems like a reasonable argument. Because the US is member at the WTO they/we are obligated by these standards. 
 
Article 39 of the TRIPS Agreement paragraph three:
This section mandates an obligation to protect data submitted for regulatory review aka drug approval or drug marketing, with a few exceptions: 

“Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.

While this provision applies to clinical trial data as lex specialis, the obligation should be interpreted in conjunction with 10bis of Paris Convention (“10bis PC”), which states:
(3) The following in particular shall be prohibited:
(i) all acts of such a nature as to create confusion by any means whatever with the establishment, the goods, or the industrial or commercial activities, of a competitor;
(ii) ...
(iii) indications or allegations the use of which in the course of trade is liable to mislead the public as to the nature, the manufacturing process, the characteristics, the suitability for their purpose, or the quantity, of the goods.

You’ve probably already read this, but thought I’d post it here in case you haven’t: https://scholarship.kentlaw.iit.edu/cgi/viewcontent.cgi?article=1149&context=ckjip

Keep up the great work!!! Transparency with this is essential. 

Love this story! 

“My CrossFit training has had probably the biggest impact on my wrestling career,” Murray said. “It’s high intensity and you’re constantly moving just like on a wrestling mat. Doing CrossFit has kept me in shape all year long.”