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Synthroid Faces Production Phase-Out, Per FDA, Until August 2003 Total Phase-Out |
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Is it a Defeat, Symbolic Hand-Slapping, or Victory for Synthroid? And What Does This Mean for Patients?
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"Nobody asks the thyroid patients how they feel about it. The drug company, and endos seem to be speaking for everyone. We may have a different story."
Donnie
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by Mary J. Shomon
July 12, 2001 -- The Food and Drug Administration (FDA) is issuing new guidance this week that tells manufacturers of unapproved thyroid medicines -- including Synthroid, the top-selling levothyroxine drug -- to phase-out production over two years, allowing for patients to switch to approved products. The FDA guidance was released today, and is titled "Guidance for Industry: Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Application." The full text of the guidance can be read online at the FDA's Internet site.
The FDA's guidance, which calls for currently marketed unapproved orally administered levothyroxine sodium products to be phased out of the market by Aug. 14, 2003, has in effect extended the approval deadline for Synthroid from August 2001 -- which itself was extended from the original deadline of August of 2000 -- yet another two years. Two levothyroxine drugs have already been approved by the FDA. Unithroid was approved in August of 2000, within the FDA's original deadline. Levoxyl was approved in May of 2001. A third drug, Levothroid, has been submitted but not yet received its FDA approval. Synthroid, the top selling thyroid drug and third most sold drug in the United States, has yet to submit an application for approval, but in a July 12th interview, Robert Hoff, M.D., Medical Director, Global Medical Communications for Abbott Labs, told About.com's Mary Shomon "We will submit our NDA by August 14, 2001." With a nine to ten-month FDA average approval timeframe, Synthroid could receive FDA approval by April or May of 2002.
Controversy had centered over the August 2001 deadline, with Abbott Labs maintaining that the deadline was for submission, and consumer groups and official FDA correspondence claiming that the deadline was for approval. The question had been whether the enforcement activities mentioned by the FDA as penalties for failure to meet the deadline would include immediate removal of Synthroid from the market. This guidance resolves that question, and leaves Synthroid on the market, although facing a reduction in availability. The guidance from the FDA requires, in fact, that Abbott reduce its sales of Synthroid by approximately 60% within one year, and to stop all sales entirely within 24 months, by August of 2003. Sales may be normally resumed if Abbott obtains FDA approval of the drug.
The phase-out schedule is, according to the FDA "...in order for manufacturers of approved products to scale up their production and for patients and health care providers to make a reasonable transition from unapproved to approved products, FDA has decided to continue to exercise its enforcement discretion by establishing a gradual phase-out of unapproved products..." In their guidance, the FDA added that "...FDA has determined that it will take time for the millions of patients taking unapproved products to switch to approved products, and for manufacturers of approved products to scale up their production and to introduce their increased production into the distribution chain."
Per the FDA guidance, the phase-out goes as follows:
- By November 1, 2001, average monthly distribution in the preceding 2 1/2 months should have been reduced to 95% of the average monthly distribution over the 6 months preceding August 1, 2001
- By February 1, 2002, average monthly distribution in the preceding 3 months should have been reduced to 90% of the average monthly distribution over the 6 months preceding August 1, 2001
- By May 1, 2002, average monthly distribution in the preceding 3 months should have been reduced to 80% of the average monthly distribution over the 6 months preceding August 1, 2001
- August 1, 2002 -- 60%
- November 2, 2002 -- 45%
- February 1, 2003 -- 30%
- May 1, 2003 -- 15%
- August 14, 2003, distribution ceases
In a press release responding to the news, Tim Fuller, Executive Director of the Gray Panthers, a group that has called for Synthroid to be more responsive to its market, has stated "The FDA agrees with consumers that Synthroid should be removed from the market. The question is no longer if it will happen but how long will patients tolerate uncertainty about Synthroid and how long will doctors tolerate risks associated with prescribing unstable and unapproved medicine?"
In a July 12, 2001 interview with Mary Shomon, Fuller indicated that he felt that the development was a victory for patients, as the FDA guidance acknowledges the problems with unapproved levothyroxine products, and seeks to take those products off the market, but in a timeframe that doesn't cut patients off too quickly and allows for sufficient time to switch to FDA-approved products.
Abbott Laboratories, in their release, cites concerns that the stepped-down distribution will create health risks by "causing patients to unnecessarily switch to products that the FDA has not determined to be therapeutically equivalent; and, add a significant cost burden to patients and the healthcare system due to additional physician visits and testing."
This statement about "therapeutically equivalence" does not address the fact that none of the products are considered bioequivalent to each other at present. The FDA, however, was clear in that they cannot verify the safety and effectiveness of Synthroid. As stated in the FDA guidance:
"As of June 2001, two orally administered levothyroxine sodium products have been approved by FDA. Unithroid, manufactured by Jerome Stevens Pharmaceuticals, was approved on August 21, 2000. Levoxyl, manufactured by Jones Pharma, was approved on May 25, 2001. These approved products have been evaluated by FDA and found to be safe and effective for their intended use. FDA has not evaluated the safety and effectiveness of unapproved marketed products, but it has determined that no currently marketed unapproved orally administered levothyroxine sodium product is generally recognized as safe and effective..." -- U.S. FDA
In a July 12th interview, Abbott's Dr. Robert Hoff told Mary Shomon: "As far as distribution step-down, we felt that it was a bit unusual. We're concerned how one can do a facilitated step-down. But we'll comply with whatever the FDA's regulations are. But in addition, we feel we have enough supply in pharmacies and wholesalers to supply patients who are taking Synthroid. Obviously the FDA will review our application and we're confident it will be approved. And then we'll be back full board with a fully approved NDA and will have full distribution at that time."
Ron Steinlauf, vice president and owner of Jerome Stevens, maker of Unithroid, wonders how the FDA will possibly be able to monitor and verify a logistically complicated scaledown such as outlined in the guidance. In a July 12, 2001 interview with mary Shomon, he said: "The FDA is essentially giving them a pass. I would like to see how the government intends to monitor Synthroid distributing less product," says Steinlauf.
According to Steinlauf, "The real issue is, is there a problem or isn't there a problem? Obviously the FDA identified certain issues and concerns with the product, but now they're gearing all their guidelines and regulations specific to that product. It's so totally inconsistent with the initial regulation from 1997, and it's inconsistent with the petition denial letter of a few months ago. I don't know why the FDA is so afraid of Abbott."
Is the FDA Caving In?
Some critics will view the guidance as the FDA caving in to the self-interest of a powerful pharmaceutical company. With a nine month approval timeframe, assurances from Abbott that there's enough Synthroid in the pipeline to maintain a steady supply for patients, and no clear way how to monitor or enforce the phase-out, the FDA's guidance in reality amounts to little more than a slap on the hand for the company, with an extension of the approval deadline.
Says Unithroid's Steinlauf, "I think the FDA should be ashamed of themselves. Look at the message it sends to manufacturers for the future. The FDA identified concerns, created solutions to address those concerns. Some adhered to them, some didn't, but now they're bending the rules to meet those who didn't comply, which makes no sense for a government agency that's supposed to be regulating the safety of products."
Why would the FDA state clearly that "no currently marketed unapproved orally administered levothyroxine sodium product is generally recognized as safe and effective..." -- clearly pointing to Synthroid -- while at the same time allowing the company even more time to comply with the August 1997 requirement for new drug application and FDA approval?
It may be a face-saving move by the FDA. The FDA would understandably be reluctant to withdraw anything from the market that they've allowed to be on the market, because it fundamentally makes them look bad and suggests that they're not doing their job. So, putting in place a seemingly harsh phase-out schedule, but one that has almost no provisions for actual monitoring or implementation, they are able to look like they are taking action, without actually affecting Synthroid's market share, availability and distribution.
What Does This Mean for Patients?
What does this latest development mean for patients? Primarily, it means that Synthroid will remain on the market, and though there may be some avaiability challenges in the time during which the phase-out is taking place until the FDA approval comes through, it's not likely to affect most patients. Be sure to check with you pharmacy, HMO or insurance company if you have any questions about what drugs they plan to carry as standard levothyroxine products so you can plan accordingly.
If You Are Newly Prescribed on Levothyroxine, What Should You Do?
If you are being prescribed levothyroxine for the first time, you may wish to ask your doctor to prescribe one of the currently FDA-approved levothyroxine products -- Unithroid or Levoxyl. This way, as Synthroid phase-out potentially affects product availability, even temporarily, you will start your treatment on an approved drug and become stabilized on an approved brand that will remain on the market without any risk of interruption whatsoever. According to research at Drugstore.com, Levoxyl is currently the less expensive of the two products, however prices may vary at local pharmacies. Both Unithroid and Levoxyl are less expensive than Synthroid, which, according to a recent Reuters report, had a price jump of 22.6% in the 12 months ending January 2001, a rate more than eight times the rate of inflation over the 1-year period.
If You Are On Synthroid And Having Problems, What Should You Do?
If you are a thyroid patient on Synthroid who is still experiencing symptoms, or having fluctuations in your TSH levels from test to test, you may wish to explore with your doctor the possibility of switching to one of the approved levothyroxine products -- Levoxyl or Unithroid -- to see if the FDA-established consistency and stability of the FDA-approved drugs helps regulate and stabilize your symptoms and TSH levels. This is particularly important given the FDA's statement states that it "has not evaluated the safety and effectiveness of unapproved marketed products, but it has determined that no currently marketed unapproved orally administered levothyroxine sodium product is generally recognized as safe and effective..."
What If You are a Thyroid Cancer Survivor?
If you are a thyroid cancer survivor, it is particularly important that you have consistent, stable levels of levothyroxine in order to suppress your thyroid and prevent thyroid cancer recurrence, so discuss any concerns you might have with your physician right away. Again, this is particularly important for patients, given the FDA's statement states that it "has not evaluated the safety and effectiveness of unapproved marketed products, but it has determined that no currently marketed unapproved orally administered levothyroxine sodium product is generally recognized as safe and effective..."
What If You Are Taking Synthroid and Doing Well?
If you are a thyroid patient who is taking Synthroid and you are stabilized and not experiencing fluctuations or symptoms, then you may wish to talk with your physician about any concerns you may have, stay up on the latest developments concerning Synthroid's approval and availability. Also, consider developing a contingency plan with your physician in the unlikely event that Synthroid is pulled off the market in August should the FDA choose to interpret that approval -- and not filing for approval -- is required before the deadline in order for Synthroid to remain on the market.
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