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Moratorium Proposed on Advertisements of Newly Approved Drugs

oad risk management strategies were not needed for every drug.

The bill is "overly onerous" and "could actually have the unintended effect of slowing down drug approvals -- while doing little to address the core issues of drug safety," Health and Human Services Secretary Mike Leavitt said in a letter to Kennedy.

The measure did not include creation of a path for FDA approval of generic biotech medicines, but Kennedy expected that would be added later.

The Senate committee also voted 11-9 to amend the bill to subject medical marijuana to FDA safety and effectiveness requirements.

The drug firms themselves charged their First Amendment rights were under attack. The First Amendment to the United States Constitution is a part of the United States Bill of Rights.

It prohibits the federal legislature from making laws that prohibit free exercise of religion or infringe on the freedom of speech or the freedom of the press and so on.

The new bill also would change incentives for pediatric research that have been lucrative for drug-makers. It would limit the extra patent time awarded for pediatric studies to three months for drugs with more than one billion dollars in annual sales. Other drugs could still receive six months.

The measure did not include creation of a path for FDA approval of generic biotech medicines, but Kennedy expected that would be added later.

The Senate committee also voted 11-9 to amend the bill to subject medical marijuana to FDA safety and effectiveness requirements.
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