The FDA won't let me see the protocol for eteplirsen

[PharmlyDoc]

so I'm researching eteplirsen for duchenne muscular dystrophy and wanted to see the clinical trial protocols submitted by Sarepta. Sarepta would not give it to me. So I contacted the FDA for a freedom of information request to see the protocols. The FDA denied the request. Shouldn't I be able to see the information that the FDA used(reviewed) to approve the drug?!

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[673441]

so I'm researching eteplirsen for duchenne muscular dystrophy and wanted to see the clinical trial protocols submitted by Sarepta. Sarepta would not give it to me. So I contacted the FDA for a freedom of information request to see the protocols. The FDA denied the request. Shouldn't I be able to see the information that the FDA used(reviewed) to approve the drug?!

Ya, that's BS... what was their reasoning for denying your request?


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[Taddy Mason]

Nope. I worked on phase II - IV clinical trials prior to med school. Phase I - III protocols are kept under "relatively" tight legal lock and key.

 

[PharmlyDoc]

In the letter they sent me it states:

"The following exemption of FOIA, 5 U.S.C. 552, are the authority for denying you access to the non disclosable material: Exemption (b)(4) Trade secret and confidential commercial information."

 

[mimelim]

so I'm researching eteplirsen for duchenne muscular dystrophy and wanted to see the clinical trial protocols submitted by Sarepta. Sarepta would not give it to me. So I contacted the FDA for a freedom of information request to see the protocols. The FDA denied the request. Shouldn't I be able to see the information that the FDA used(reviewed) to approve the drug?!

In the letter they sent me it states:

"The following exemption of FOIA, 5 U.S.C. 552, are the authority for denying you access to the non disclosable material: Exemption (b)(4) Trade secret and confidential commercial information."

What exactly is your confusion? They told you exactly why they won't give it to you.

Just in case you need it spelled out for you. No, you shouldn't be able to see the information because there are trade secrets or confidential commercial information in those document which is one of the 9 exemptions from the Freedom of Information Act.

 

[ChrisMack390]

As is often said in the pre-allo forum, the entitlement is strong in this one.

 

[GH253]

Ya, that's BS... what was their reasoning for denying your request?


Sent from my iPhone using SDN mobile

Why, they're protecting the public interest, of course!

 

[Test Monkey]

In the letter they sent me it states:

"The following exemption of FOIA, 5 U.S.C. 552, are the authority for denying you access to the non disclosable material: Exemption (b)(4) Trade secret and confidential commercial information."

You can find the review online. Trade secrets are redacted.

LINK: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206488_TOC.cfm