The FDA has been denied its back door attempt at establishing tougher hgh rules without having to hold hearings and show proof of danger. Now nothing will change unless Congress acts which is doubtful in an election year. So it looks like things are currently stalemated at the current level of over regulation.
From the FDA Law Blog:
The Commission declined to adopt the following FDA recommendations:
1. to amend the Guidelines to explicitly cover human growth hormone (hGH) offenses;
2. to amend the Guidelines to increase the sentences for Prescription Drug Marketing Act offenses;
3. to amend the Guidelines so that the value of any FDC Act regulated product (drug, device, food) would be zero if that product were deemed adulterated or misbranded under the FDC Act.
Absent congressional action, these proposed amendments will become effective on November 1, 2008.
Read the full story at:
Power To The People!
Now we just need the FDA to explain why they regulate human growth hormone to a more rigorous standard than most other prescription drugs. Maybe even get them to supply some factual documentation.
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