Kaye
01-27-2011, 12:26 PM
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2011/01/regenerative-sciences-fda-struggle-continues.html
Regenerative Sciences ? FDA Struggle Continues
By William T. Koustas ?
We previously reported on the struggle between FDA and Regenerative Sciences, Inc. (?Regenerative?) in which Regenerative challenged FDA?s claim that the company?s stem cell procedure is subject to FDA jurisdiction and regulation under the Federal Food, Drug, and Cosmetic Act (?FDCA?) and/or the Public Health Service Act (?PHSA?) as the manufacture and sale of an unapproved drug and/or biologic. (See our previous posts here, here, and here.) Regenerative has developed a procedure in which stem cells are isolated from a patient?s bone marrow, undergo an expansion in a laboratory and are then returned to the patient?s site of injury to treat musculoskeletal and spinal injuries (?Regenexx Procedure?).
Regenerative filed a lawsuit against FDA in February 2009 in response to an FDA letter and inspection of its laboratory seeking declaratory and injunctive relief from FDA?s regulation of the Regenexx Procedure, arguing that the stem cells used in that procedure are not drugs or biologics and the Regenexx Procedure is the practice of medicine which is outside of FDA?s jurisdiction. Regenerative?s February 2009 lawsuit was dismissed on ripeness grounds, but Regenerative filed another complaint in June 2010 after FDA conducted an inspection on Regenerative?s facility in February and March 2009, which culminated in FDA issuing a Form 483. In response, FDA filed a complaint in August 2010 seeking to permanently enjoin Regenerative from using stem cells to treat patients without approval. The Court eventually issued an order denying Regenerative?s motion for a temporary restraining order in its June 2010 complaint as moot because Regenerative agreed to voluntarily discontinue the use of the Regenexx Procedure while the August 2010 case is pending. The Court also entered a stay while the related August 2010 case is litigated.
Now, the U.S. Justice Department, on behalf of FDA (?the Government?), has filed a motion for summary judgment and a motion to dismiss Regenerative?s counterclaims.
The Government?s January 7, 2011, motion for summary judgment claims that there is no issue of material fact in the case as Regenerative is manufacturing a ?drug? (the cultured stem cells) that is being held for sale ?after one or more of its components have been shipped in interstate commerce,? and that such a drug is adulterated since Regenerative is not complying with current Good Manufacturing Practices. The Government further argues that, as a drug, Regenerative?s stem cells are misbranded as they do not bear the symbol ?Rx only? and do not have adequate directions for use. In response to Regenerative?s argument that the Regenexx Procedure is the practice of medicine outside of FDA?s jurisdiction, the Government asserts that while FDA may not ?interfere with a physician prescribing lawfully marketed products for uses other than those for which they are approved, licensed, or cleared by FDA, the agency?s role in determining the availability of therapeutic products inevitably affects the options available to practitioners seeking to use or prescribe those products.? Thus, the Government appears to claim that FDA may not directly interfere with a physician?s prescribing habits, but it may limit what drugs are available to physicians to prescribe in the U.S. market. Accordingly, the Government argues that FDA is not impinging on Regenerative?s ability to practice medicine as it is only requiring a drug product to be approved for sale in the U.S.
In addition to the motion for summary judgment, the Government also filed a motion to dismiss Regenerative?s counterclaims. Regenerative claims that FDA?s attempt to regulate stem cells as used in the Regenexx Procedure constitutes the regulation of the practice of medicine and that FDA?s human cell, tissue or cellular or tissue-based product (?HCT/P?) rule?s definition of ?minimal manipulation? is arbitrary and capricious and should have been issued through notice-and-comment rulemaking. As with its motion for summary judgment, the Government asserts that Regenerative?s counterclaims alleging that the Regenexx Procedure is the practice of medicine should be dismissed under similar reasoning as described above while also noting that the FDCA applies to drugs manufactured by physicians. The motion to dismiss also takes issue with Regenerative?s counterclaims regarding FDA?s HCT/P rule. Regenerative argues that preamble statements regarding ?minimal manipulation? in the HCT/P rule ?imposed a per se rule which provides that any expansion of stem cells constitutes more than minimal manipulation? without explaining how such expansion alters biological characteristics of the cells. The Government argues that such statements in the preamble are not part of the rule requiring notice-and-comment rulemaking as that statement was just a policy statement clarifying the rule.
The Government further claims that Regenerative?s challenge to the HCT/P rule, which was issued in 2001, is time barred as the chalenge was not filed within six years of the rule being issued as required by 28 U.S.C. ? 2401. The Government asserts that Administrative Procedure Act claims are governed by a ?catch-all? statute of limitations of six years after the right of action accrues as described in 28 U.S.C. ? 2401(a) unless a different statute requires a different timeframe. The Government argues that a cause of action accrues when the regulation is applied to the claimant (if the challenge to the rule is based on substantive grounds) or when the regulation is issued (if the challenge to the rule is based on procedural grounds). Since it is clear that the rule has been applied to Regenerative within the last six years, the Government argues that Regenerative?s counterclaims relating to the HCT/P rule are procedural in nature, and are therefore time barred.
Listed below are links to weblogs that reference Regenerative Sciences ? FDA Struggle Continues:
Comments
This is Doctor Centeno. One of our physicians alerted me to these blog posts which concern our clinic, so I thought it appropriate to reply. At the end of the day, we sued FDA four times to get them to sue us. Basically, FDA claimed it had authority to tell a physician how to practice medicine and we challenged that authority. During our challenges, FDA claimed that it hadn't made up its mind (for two years) about how it would decide to act in considering our culturing of a patient's own stem cells the same as a new drug. This created a legal conundrum called "ripeness". As an example of the doctrine of ripeness, if the government shows up tomorrow and wants to blow up your house, you generally can't question it's authority to blow up your house until after your house is blown up-meaning until the government takes some action you can't question whether they have the authority to take the action. Hence, we had to poke the tiger 4 times to get the tiger to come out of its cage and "take an action". We're now thankfully in a situation where we can challenge the government?s authority to control the practice of medicine, something congress and the courts have repeatedly barred the FDA from doing.
This is a very big and seminal case. At its heart is whether the stem cells in your body are drugs to be federally regulated or body parts to use as you and your doctor see fit. These two outcomes have huge societal impacts. If they are drugs, then expect an expensive and slow adoption of adult stem cells as therapy. Some diseases will never be treated with cells because the cost of FDA approval (about 500 M USD) won't support the disease market and the cost of cells being used "off-label" will be astronomical because of the 500 M USD approval cost per disease. We believe there will be adverse societal impacts to this slow adoption that will show up as an increase morbidity and mortality (for a scientific discussion of how this is measured, see FDAReview.org, a project of The Independent Institute ). If the stem cells in your body are in fact body parts and physicians are free to practice using those body parts with responsible medicine, then there will be a rapid adoption of these new tools.
In summary, this is a very big and important case and appreciate you following it.
Chris Centeno, M.D.
Posted by: Chris Centeno, M.D. | January 21, 2011 at 09:20 AM
Regenerative Sciences ? FDA Struggle Continues
By William T. Koustas ?
We previously reported on the struggle between FDA and Regenerative Sciences, Inc. (?Regenerative?) in which Regenerative challenged FDA?s claim that the company?s stem cell procedure is subject to FDA jurisdiction and regulation under the Federal Food, Drug, and Cosmetic Act (?FDCA?) and/or the Public Health Service Act (?PHSA?) as the manufacture and sale of an unapproved drug and/or biologic. (See our previous posts here, here, and here.) Regenerative has developed a procedure in which stem cells are isolated from a patient?s bone marrow, undergo an expansion in a laboratory and are then returned to the patient?s site of injury to treat musculoskeletal and spinal injuries (?Regenexx Procedure?).
Regenerative filed a lawsuit against FDA in February 2009 in response to an FDA letter and inspection of its laboratory seeking declaratory and injunctive relief from FDA?s regulation of the Regenexx Procedure, arguing that the stem cells used in that procedure are not drugs or biologics and the Regenexx Procedure is the practice of medicine which is outside of FDA?s jurisdiction. Regenerative?s February 2009 lawsuit was dismissed on ripeness grounds, but Regenerative filed another complaint in June 2010 after FDA conducted an inspection on Regenerative?s facility in February and March 2009, which culminated in FDA issuing a Form 483. In response, FDA filed a complaint in August 2010 seeking to permanently enjoin Regenerative from using stem cells to treat patients without approval. The Court eventually issued an order denying Regenerative?s motion for a temporary restraining order in its June 2010 complaint as moot because Regenerative agreed to voluntarily discontinue the use of the Regenexx Procedure while the August 2010 case is pending. The Court also entered a stay while the related August 2010 case is litigated.
Now, the U.S. Justice Department, on behalf of FDA (?the Government?), has filed a motion for summary judgment and a motion to dismiss Regenerative?s counterclaims.
The Government?s January 7, 2011, motion for summary judgment claims that there is no issue of material fact in the case as Regenerative is manufacturing a ?drug? (the cultured stem cells) that is being held for sale ?after one or more of its components have been shipped in interstate commerce,? and that such a drug is adulterated since Regenerative is not complying with current Good Manufacturing Practices. The Government further argues that, as a drug, Regenerative?s stem cells are misbranded as they do not bear the symbol ?Rx only? and do not have adequate directions for use. In response to Regenerative?s argument that the Regenexx Procedure is the practice of medicine outside of FDA?s jurisdiction, the Government asserts that while FDA may not ?interfere with a physician prescribing lawfully marketed products for uses other than those for which they are approved, licensed, or cleared by FDA, the agency?s role in determining the availability of therapeutic products inevitably affects the options available to practitioners seeking to use or prescribe those products.? Thus, the Government appears to claim that FDA may not directly interfere with a physician?s prescribing habits, but it may limit what drugs are available to physicians to prescribe in the U.S. market. Accordingly, the Government argues that FDA is not impinging on Regenerative?s ability to practice medicine as it is only requiring a drug product to be approved for sale in the U.S.
In addition to the motion for summary judgment, the Government also filed a motion to dismiss Regenerative?s counterclaims. Regenerative claims that FDA?s attempt to regulate stem cells as used in the Regenexx Procedure constitutes the regulation of the practice of medicine and that FDA?s human cell, tissue or cellular or tissue-based product (?HCT/P?) rule?s definition of ?minimal manipulation? is arbitrary and capricious and should have been issued through notice-and-comment rulemaking. As with its motion for summary judgment, the Government asserts that Regenerative?s counterclaims alleging that the Regenexx Procedure is the practice of medicine should be dismissed under similar reasoning as described above while also noting that the FDCA applies to drugs manufactured by physicians. The motion to dismiss also takes issue with Regenerative?s counterclaims regarding FDA?s HCT/P rule. Regenerative argues that preamble statements regarding ?minimal manipulation? in the HCT/P rule ?imposed a per se rule which provides that any expansion of stem cells constitutes more than minimal manipulation? without explaining how such expansion alters biological characteristics of the cells. The Government argues that such statements in the preamble are not part of the rule requiring notice-and-comment rulemaking as that statement was just a policy statement clarifying the rule.
The Government further claims that Regenerative?s challenge to the HCT/P rule, which was issued in 2001, is time barred as the chalenge was not filed within six years of the rule being issued as required by 28 U.S.C. ? 2401. The Government asserts that Administrative Procedure Act claims are governed by a ?catch-all? statute of limitations of six years after the right of action accrues as described in 28 U.S.C. ? 2401(a) unless a different statute requires a different timeframe. The Government argues that a cause of action accrues when the regulation is applied to the claimant (if the challenge to the rule is based on substantive grounds) or when the regulation is issued (if the challenge to the rule is based on procedural grounds). Since it is clear that the rule has been applied to Regenerative within the last six years, the Government argues that Regenerative?s counterclaims relating to the HCT/P rule are procedural in nature, and are therefore time barred.
Listed below are links to weblogs that reference Regenerative Sciences ? FDA Struggle Continues:
Comments
This is Doctor Centeno. One of our physicians alerted me to these blog posts which concern our clinic, so I thought it appropriate to reply. At the end of the day, we sued FDA four times to get them to sue us. Basically, FDA claimed it had authority to tell a physician how to practice medicine and we challenged that authority. During our challenges, FDA claimed that it hadn't made up its mind (for two years) about how it would decide to act in considering our culturing of a patient's own stem cells the same as a new drug. This created a legal conundrum called "ripeness". As an example of the doctrine of ripeness, if the government shows up tomorrow and wants to blow up your house, you generally can't question it's authority to blow up your house until after your house is blown up-meaning until the government takes some action you can't question whether they have the authority to take the action. Hence, we had to poke the tiger 4 times to get the tiger to come out of its cage and "take an action". We're now thankfully in a situation where we can challenge the government?s authority to control the practice of medicine, something congress and the courts have repeatedly barred the FDA from doing.
This is a very big and seminal case. At its heart is whether the stem cells in your body are drugs to be federally regulated or body parts to use as you and your doctor see fit. These two outcomes have huge societal impacts. If they are drugs, then expect an expensive and slow adoption of adult stem cells as therapy. Some diseases will never be treated with cells because the cost of FDA approval (about 500 M USD) won't support the disease market and the cost of cells being used "off-label" will be astronomical because of the 500 M USD approval cost per disease. We believe there will be adverse societal impacts to this slow adoption that will show up as an increase morbidity and mortality (for a scientific discussion of how this is measured, see FDAReview.org, a project of The Independent Institute ). If the stem cells in your body are in fact body parts and physicians are free to practice using those body parts with responsible medicine, then there will be a rapid adoption of these new tools.
In summary, this is a very big and important case and appreciate you following it.
Chris Centeno, M.D.
Posted by: Chris Centeno, M.D. | January 21, 2011 at 09:20 AM