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Synthroid News Recap -- July 17, 2001 |
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A Look at Recent Coverage of the FDA New Drug Approval Controversy Surrounding Synthroid
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Join the Discussion
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"I am unaware of any other T4 manufacturer except for the makers of Synthroid that have put up such a fight and spent who knows how much in resources to argue against having to meet the FDA's requirements (and to pump themselves up to consumers, pharmacists, doctors)...I'd like to know why they are dragging their feet and spending so much money to court the pharmacists and docs. How about using those resources to meet the requirements of the FDA?"
Toto
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by Mary J. Shomon
Last week, the FDA released new guidance on levothyroxine sodium products that effectively extended Synthroid's deadline for approval of its new drug application, while introducing the possibility of reduced production of the heavily prescribed thyroid drug.
The news coverage of this issue has been quite heavy, and here's a recap of what coverage has been recently taking place, and where.
- July 11, 2001 -- Synthroid Press Release
Having somehow acquired advance notice of the FDA guidance, Abbott Labs/Synthroid issued a press release to say that they wanted to assure the public that Synthroid would remain on the market while the new drug application review was occurring.
- July 12, 2001 -- Synthroid Faces Production Phase-Out, Per FDA, Until August 2003 Total Phase-Out
In About.com's own summary, thyroid guide Mary Shomon looked at whether the FDA guidance is a defeat, a symbolic hand-slapping, or victory for Synthroid, and what it means for patients.
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July 12, 2001 -- Gray Panthers' Press Release
The Gray Panthers felt that the FDA guidance was a victory for consumers, and outlined their reasons in a press release issued on Thursday, July 12.
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July 12 -- Synthroid Setback: FDA Says Companies May Have to Cut Thyroid Drug Distribution (ABC News)
Among those affected could be the popular drug Synthroid.
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July 12 -- Thyroid Drugs Face Approval Deadline (Associated Press)
The government has advised makers of some widely used thyroid drugs that they will have to begin cutting back distribution of any that haven't won agency approval by Aug. 14.
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July 12 -- FDA Will Not Yet Withdraw Unapproved Thyroid Drug (Reuters)
In a move partially meant to allay the fears of the millions of Americans taking Synthroid, the US Food and Drug Administration (FDA) clarified on Thursday that the agency has given makers of the thyroid drug until August 14 to file for approval.
- July 14 -- Mary Shomon Interviewed on ABC's World News Tonight
In a national news broadcast, patient activist, author and About's thyroid guide Mary Shomon was interviewed for a news segment on the Synthroid controversy, which was featured on ABC's World News Tonight on Saturday, July 14. (NOTE: this link will allow you to view the entire ABC news clip in RealPlayer, select "FDA Insists Synthroid Gain Approval, World News Tonight, Date:07-14-2001, Correspondent:Terry Moran, Jim Sciutto" to view the segment featuring Mary Shomon.)
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July 13 -- Abbott Told to Reduce Supply of Unapproved Thyroid Drug
The Food and Drug Administration said yesterday that Abbott Laboratories must gradually reduce its distribution of a highly prescribed thyroid drug while it applies for regulatory approval of the medication.
- July 14 -- Thyroid drug's demise possible (The Tampa Tribune)
In an detailed article that quotes About.com's thyroid guide Mary Shomon, Tampa Tribune health writer Patty Ryan takes an in-depth look at whether Synthroid's "days are numbered."
- July 17, 2001 -- Today Show Covers Synthroid
The Today Show on Tuesday, July 17, 2001 featured a segment with host Katie Couric interviewing Paul Ladenson, M.D., head of the American Thyroid Association. Ladenson, whose group relies on funding from the manufacturers of Synthroid (see the ATA sponsorship page, http://www.thyroid.org/sponsors/sponsors.htm) presented an optimistic picture of the current Synthroid situation that was consistent with his organization's vocal support for Synthroid, as demonstrated by the press release on their site.
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