If you and your patients have been suffering under the onerous iPLEDGE program, then you and your patients may be wondering how all of this will ultimately sort out. Although I don’t claim to have any hard-and-fast answers, I have been considering some legal bases to challenge iPLEDGE.
In this article, I’ll discuss some of these possible challenges to iPLEDGE. However, I must first offer the caveat that although I went to law school and am a member of the New York State Bar, I practice dermatology and not law. Whether my legal review is sound or viable or can provide a basis to effect change, I can only speculate and will leave for others to judge.
Born of Good Intentions
I believe that those who want to restrict the use of isotretinoin (Accutane, Amnesteem, Claravis, Sotret) believe that they are doing good. The members of March of Dimes are weary of marching; they don’t want to see any babies with birth defects in their time. For them, iPLEDGE is one more puzzle wedge pushed in against another puzzle wedge, and when all the wedges are apposed a world free from pathologic congenital abnormalities will appear.
The moment of an abortion is an unhappy moment from every angle, but a different understanding of the consequences of abortion as it relates to personal and societal happiness separates those who are pro-life from those who are pro-choice. Pro-life and pro-choice partisans undoubtedly agree that every moment spent under the mask of disfiguring acne is an unhappy moment and even a continual torment. They might only differ on the implications of therapeutic options that free patients from acne’s scarring effects.
Looking More Carefully at the Legality of iPLEDGE
The following regulation brought iPLEDGE into effect: 21 Code of Federal Regulations 314, Subpart H.
When considering the legal basis for challenging iPLEDGE, it is important to note that there is no federal right to healthcare in the United States. Harris v. McRae. 448 U.S. 297 (1980) (“states participating in the Medicaid program were not obligated to fund medically necessary abortions under Title XIX”).
Patients’ Bill of Rights
Some states, however, have in effect a patients’ bill of rights (e.g. 381.026 Florida Patient’s Bill of Rights and Responsibilities).
While federal law typically preempts state law, this does not mean that a federal law or regulation cannot be challenged under a state law. Even though the courts always show great deference to the FDA, in matters protecting public safety, if patients as plaintiffs can adduce evidence that a state’s patients’ bill of rights is being violated by iPLEDGE, a cause of action challenging the existence of iPLEDGE could be brought, although it might not succeed.
If no viable cause of action can be founded under a state’s patients’ bill of rights, then perhaps the advocates for a federal “patients’ bill of rights” might find additional advocates and support for their cause. If Congress enacts a federal “patients’ bill of rights”, this might allow patients to challenge iPLEDGE as an obstruction of their access to care. A way to counteract regulatory fait is to accord those who are subject to regulation a legal right to challenge the regulation that affects them.
The iPLEDGE system virtually and in reality denies isotretinoin to certain specific (and some possibly could say protected) classes of persons in the United States. The constitution affords “equal protection” to all U.S. inhabitants. Persons in prison (a group of 1 to
1.5 million Americans) do not have ready (and often any) access to computers and to phones. Without a phone or an Internet connection, a patient who happens to be incarcerated can not obtain isotretinoin under any circumstances as iPLEDGE stands.
This lack of access to phones (except for family and legal matters) and computers is founded (I am convinced wholly correctly) on protecting public safety. I defer to the prison authorities and courts in this regard. However, an advocate for public health could find iPLEDGE immiscible to public health and favor a prisoner’s access to isotretinoin and, at the same time, not want the prisoner to have access to phones or the Internet in a fashion that is not consistent with good penal practice.
As such, an interested party could challenge iPLEDGE on the basis of a denial of equal protection. In passing, I should note that in Goodman & United States v. Georgia 546 US ___ (2006), the Supreme Court found that the Americans with Disabilities Act protects people held in a state prison from discrimination by prison officials. Perhaps someone might take up the cause of defending prisoners against FDA regulations with which the prisoners cannot comply — and in so doing reveal the contradictions of the iPLEDGE system.
Americans with Disabilities
Taking this idea further, might not persons with nodulocystic acne be considered to be “a protected class,” under the Americans with Disability’s Act as identifiable persons who suffer from discrimination and disability?
Cunliffe, in his article titled “Acne and unemployment” (Br J Dermatol. 1986 Sep;115(3):386.), noted that persons with severe acne have a much higher rate of unemployment than those with clear, acne-free skin. Disfiguring acne is a visible stigma that cannot be hidden.
The Supreme Courts has mandated that public facilities accommodate those who have disabilities; however, the courts have not required that those with disabilities accommodate themselves to political considerations.
If a plaintiff under the Americans with Disability’s Act, with severe disabling nodulocystic acne made a claim that iPLEDGE resulted in an inhibition in his or her ability to obtain isotretinoin, a legally approved medication, needed to cure his or her disease or a denial of medical care, might not iPLEDGE at least be challenged, delayed, reworked or reconsidered?
STEPS Is Not a Good Model for iPLEDGE
The use of inapposite regulatory analogs should prompt patient and physician concern and possible judicial intervention. The STEPS program, which regulates thalidomide, has been touted as a demonstration of a workable regulatory schema for teratogenic medication control. STEPS is not instructive for the functioning of iPLEDGE. Even though the STEPS program allowed thalidomide to come back to the market in the United States, it was a founded on a legal fiction.
I once asked representatives from Cellgene, the manufacturers of thalidomide, how many cases of erythema nodosum leporsum (for which thalidomide is approved), were in the United States. This was back in 2002, and the company representative ventured a guess of about a dozen patients.
I know that patients with multiple myeloma, lupus and other diseases are prescribed thalidomide — but these amounts of patients are a fraction of the number of patients who suffer from acne. iPLEDGE affects tens of thousands of patients with acne who have had no voice in a system rendered as a regulatory fait a compli.
The Government Can Not Practice Medicine
Although the FDA is empowered by Congress to ensure the safety of medications, it is the duty of the FDA to allow physicians to practice medicine. The legal power of 21 Code of Federal Regulations 314, Subpart H legally reified iPLEDGE. However, a regulation lacks the legal heft that a court might accord a law passed by Congress or a provision of the Constitution and hence is more susceptible to legal challenge.
Part of the intention of the Federal Food Drug and Cosmetic Act of 1938 and the Drug amendments of 1962 was to state that the FDA was not to interfere with the practice of medicine. Congress has repeatedly stated that physicians may prescribe medications for diseases based on their medical judgment, rather than based on the package insert. One could posit that iPLEDGE is legally unsound or at least requires reworking as an interference with the practice of medicine that Congress has expressly forbidden to grant the FDA
in the past. It is possible that a professional association could ask a court (perhaps for declaratory relief) to jive Congress’s legislative direction with the FDA’s dictum.
A Legally Overbroad Program?
iPLEDGE might also be considered to be legally overbroad, even by a court showing deference to the special expertise of FDA and its regulatory panels and advisory boards. While narcotics, which are addictive and potentially fatal, merit close monitoring, it is hard to understand a legally sound regulatory framework in which isotretinoin is monitored even more closely than narcotics.
If a Jehovah’s witness can refuse a transfusion, then why can’t a patient, for the sake of argument on religious grounds, refuse to be made to choose abstinence or contraception in order to receive the medically established care they desire?
The iPLEDGE system treats lifesaving isotretinoin as it does isotretinoin for acne. Isotretinoin is lifesaving for neuroblastoma, a fast growing cancer in children. iPLEDGE might impede its prescription and utilization for treatment of this killer cancer. If iPLEDGE halts the use of isotretinoin for 1 day, in one child, or steals 1 day of life, then the parent of such a child might have grounds to legally challenge iPLEDGE as overburdensome or overbroad.
FDA Is Not Invincible
The FDA is not like the “invincible Jupiter” — a god of the Romans who could not know retreat. Numerous groups have challenged regulations proposed or implemented by the FDA and had the FDA’s regulations amended or appended.
This was the case in Washington Legal Foundation v. Friedman. The FDA tried to limit the dissemination of “off-label” information. A district court rebuffed the FDA’s actions. The FDA appealed a district court decision holding that the Food and Drug Administration Modernization Act of 1997 (FDAMA), which established procedures by which drug and medical device manufacturers could disseminate information about “off-label” uses for their products, violated the First Amendment.
In the end, the FDA admitted that the statute did not provide it with independent authority to proscribe speech, and the case ended. Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998); Washington Legal Foundation v. Friedman, 56 F. Supp. 2d 81 (D.D.C. 1999) dismissed, 202 F.3d 331 (DC. Cir. 2000).
Another First Amendment case challenging the FDA involved pharmaceutical regulations that were cast to provide an expansive regulatory framework, rather than restrictive ones. This case involved the FDAMA prohibition on soliciting prescriptions for and advertising for compounded drugs. These restrictions on the dissemination of information regarding compounding of medications were found to have unconstitutional restrictions on commercial speech. Tommy G. Thompson v. Western States Medical Center. 535 U.S. 357; 122 S. Ct. 1497; 152 L. Ed. 2d 563 (2002) applying the schema of Central Hudson Gas & Elec. Corp. v. Public Serv. Comm’n of N. Y., 447 U.S. 557, 566, 65 L. Ed. 2d 341, 100 S. Ct. 2343.
While Washington and Western are cases applying the First Amendment, they demonstrate that FDA and its medication regulation are issues within the purview of the courts — even if the regulations involve health and safety issues.
Raising Issues
The issues I have addressed remain open; their consideration is ongoing. However, iPLEDGE is now the law. I must concede that I know only the healing powers of isotretinoin. I have never had a patient nor spoken to a doctor who had a patient with a baby with birth defects caused by isotretinoin. I hope I never do, and my heart goes out to those who have suffered.
I believe that the people who advise and head the FDA and the advocates of isotretinoin restriction, such as Representative Stupak (whose son was taking isotretinoin at the time when he committed suicide), profoundly and sincerely believe that their actions in regard to isotretinoin enhance Americans’ general welfare and commonweal. I admire the fervor of their work and convictions in this regard.
Patients and doctors do not have to surrender their common sense or their ideals. Patients and physicians are not without a political voice or a means of legal recourse when they believe they are legally ill-served and beset. The laws and regulations that rule America are not immutable. Rather, they are a process in constant evolution.
Patients and physicians must decide if they believe they should accept iPLEDGE. It is also possible that the iPLEDGE legal schema is not legally sound. The legal soundness of iPLEDGE is something patients and physicians should consider and reconsider and address judicially and politically if they view it as legally unsound or unjust. They are entitled, and some would say obliged, to ask the courts in reference to the actions of the FDA regarding iPLEDGE Sed quis custodiet ipsos custodes? (Who Will Watch the Watchmen?)
If you and your patients have been suffering under the onerous iPLEDGE program, then you and your patients may be wondering how all of this will ultimately sort out. Although I don’t claim to have any hard-and-fast answers, I have been considering some legal bases to challenge iPLEDGE.
In this article, I’ll discuss some of these possible challenges to iPLEDGE. However, I must first offer the caveat that although I went to law school and am a member of the New York State Bar, I practice dermatology and not law. Whether my legal review is sound or viable or can provide a basis to effect change, I can only speculate and will leave for others to judge.
Born of Good Intentions
I believe that those who want to restrict the use of isotretinoin (Accutane, Amnesteem, Claravis, Sotret) believe that they are doing good. The members of March of Dimes are weary of marching; they don’t want to see any babies with birth defects in their time. For them, iPLEDGE is one more puzzle wedge pushed in against another puzzle wedge, and when all the wedges are apposed a world free from pathologic congenital abnormalities will appear.
The moment of an abortion is an unhappy moment from every angle, but a different understanding of the consequences of abortion as it relates to personal and societal happiness separates those who are pro-life from those who are pro-choice. Pro-life and pro-choice partisans undoubtedly agree that every moment spent under the mask of disfiguring acne is an unhappy moment and even a continual torment. They might only differ on the implications of therapeutic options that free patients from acne’s scarring effects.
Looking More Carefully at the Legality of iPLEDGE
The following regulation brought iPLEDGE into effect: 21 Code of Federal Regulations 314, Subpart H.
When considering the legal basis for challenging iPLEDGE, it is important to note that there is no federal right to healthcare in the United States. Harris v. McRae. 448 U.S. 297 (1980) (“states participating in the Medicaid program were not obligated to fund medically necessary abortions under Title XIX”).
Patients’ Bill of Rights
Some states, however, have in effect a patients’ bill of rights (e.g. 381.026 Florida Patient’s Bill of Rights and Responsibilities).
While federal law typically preempts state law, this does not mean that a federal law or regulation cannot be challenged under a state law. Even though the courts always show great deference to the FDA, in matters protecting public safety, if patients as plaintiffs can adduce evidence that a state’s patients’ bill of rights is being violated by iPLEDGE, a cause of action challenging the existence of iPLEDGE could be brought, although it might not succeed.
If no viable cause of action can be founded under a state’s patients’ bill of rights, then perhaps the advocates for a federal “patients’ bill of rights” might find additional advocates and support for their cause. If Congress enacts a federal “patients’ bill of rights”, this might allow patients to challenge iPLEDGE as an obstruction of their access to care. A way to counteract regulatory fait is to accord those who are subject to regulation a legal right to challenge the regulation that affects them.
The iPLEDGE system virtually and in reality denies isotretinoin to certain specific (and some possibly could say protected) classes of persons in the United States. The constitution affords “equal protection” to all U.S. inhabitants. Persons in prison (a group of 1 to
1.5 million Americans) do not have ready (and often any) access to computers and to phones. Without a phone or an Internet connection, a patient who happens to be incarcerated can not obtain isotretinoin under any circumstances as iPLEDGE stands.
This lack of access to phones (except for family and legal matters) and computers is founded (I am convinced wholly correctly) on protecting public safety. I defer to the prison authorities and courts in this regard. However, an advocate for public health could find iPLEDGE immiscible to public health and favor a prisoner’s access to isotretinoin and, at the same time, not want the prisoner to have access to phones or the Internet in a fashion that is not consistent with good penal practice.
As such, an interested party could challenge iPLEDGE on the basis of a denial of equal protection. In passing, I should note that in Goodman & United States v. Georgia 546 US ___ (2006), the Supreme Court found that the Americans with Disabilities Act protects people held in a state prison from discrimination by prison officials. Perhaps someone might take up the cause of defending prisoners against FDA regulations with which the prisoners cannot comply — and in so doing reveal the contradictions of the iPLEDGE system.
Americans with Disabilities
Taking this idea further, might not persons with nodulocystic acne be considered to be “a protected class,” under the Americans with Disability’s Act as identifiable persons who suffer from discrimination and disability?
Cunliffe, in his article titled “Acne and unemployment” (Br J Dermatol. 1986 Sep;115(3):386.), noted that persons with severe acne have a much higher rate of unemployment than those with clear, acne-free skin. Disfiguring acne is a visible stigma that cannot be hidden.
The Supreme Courts has mandated that public facilities accommodate those who have disabilities; however, the courts have not required that those with disabilities accommodate themselves to political considerations.
If a plaintiff under the Americans with Disability’s Act, with severe disabling nodulocystic acne made a claim that iPLEDGE resulted in an inhibition in his or her ability to obtain isotretinoin, a legally approved medication, needed to cure his or her disease or a denial of medical care, might not iPLEDGE at least be challenged, delayed, reworked or reconsidered?
STEPS Is Not a Good Model for iPLEDGE
The use of inapposite regulatory analogs should prompt patient and physician concern and possible judicial intervention. The STEPS program, which regulates thalidomide, has been touted as a demonstration of a workable regulatory schema for teratogenic medication control. STEPS is not instructive for the functioning of iPLEDGE. Even though the STEPS program allowed thalidomide to come back to the market in the United States, it was a founded on a legal fiction.
I once asked representatives from Cellgene, the manufacturers of thalidomide, how many cases of erythema nodosum leporsum (for which thalidomide is approved), were in the United States. This was back in 2002, and the company representative ventured a guess of about a dozen patients.
I know that patients with multiple myeloma, lupus and other diseases are prescribed thalidomide — but these amounts of patients are a fraction of the number of patients who suffer from acne. iPLEDGE affects tens of thousands of patients with acne who have had no voice in a system rendered as a regulatory fait a compli.
The Government Can Not Practice Medicine
Although the FDA is empowered by Congress to ensure the safety of medications, it is the duty of the FDA to allow physicians to practice medicine. The legal power of 21 Code of Federal Regulations 314, Subpart H legally reified iPLEDGE. However, a regulation lacks the legal heft that a court might accord a law passed by Congress or a provision of the Constitution and hence is more susceptible to legal challenge.
Part of the intention of the Federal Food Drug and Cosmetic Act of 1938 and the Drug amendments of 1962 was to state that the FDA was not to interfere with the practice of medicine. Congress has repeatedly stated that physicians may prescribe medications for diseases based on their medical judgment, rather than based on the package insert. One could posit that iPLEDGE is legally unsound or at least requires reworking as an interference with the practice of medicine that Congress has expressly forbidden to grant the FDA
in the past. It is possible that a professional association could ask a court (perhaps for declaratory relief) to jive Congress’s legislative direction with the FDA’s dictum.
A Legally Overbroad Program?
iPLEDGE might also be considered to be legally overbroad, even by a court showing deference to the special expertise of FDA and its regulatory panels and advisory boards. While narcotics, which are addictive and potentially fatal, merit close monitoring, it is hard to understand a legally sound regulatory framework in which isotretinoin is monitored even more closely than narcotics.
If a Jehovah’s witness can refuse a transfusion, then why can’t a patient, for the sake of argument on religious grounds, refuse to be made to choose abstinence or contraception in order to receive the medically established care they desire?
The iPLEDGE system treats lifesaving isotretinoin as it does isotretinoin for acne. Isotretinoin is lifesaving for neuroblastoma, a fast growing cancer in children. iPLEDGE might impede its prescription and utilization for treatment of this killer cancer. If iPLEDGE halts the use of isotretinoin for 1 day, in one child, or steals 1 day of life, then the parent of such a child might have grounds to legally challenge iPLEDGE as overburdensome or overbroad.
FDA Is Not Invincible
The FDA is not like the “invincible Jupiter” — a god of the Romans who could not know retreat. Numerous groups have challenged regulations proposed or implemented by the FDA and had the FDA’s regulations amended or appended.
This was the case in Washington Legal Foundation v. Friedman. The FDA tried to limit the dissemination of “off-label” information. A district court rebuffed the FDA’s actions. The FDA appealed a district court decision holding that the Food and Drug Administration Modernization Act of 1997 (FDAMA), which established procedures by which drug and medical device manufacturers could disseminate information about “off-label” uses for their products, violated the First Amendment.
In the end, the FDA admitted that the statute did not provide it with independent authority to proscribe speech, and the case ended. Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998); Washington Legal Foundation v. Friedman, 56 F. Supp. 2d 81 (D.D.C. 1999) dismissed, 202 F.3d 331 (DC. Cir. 2000).
Another First Amendment case challenging the FDA involved pharmaceutical regulations that were cast to provide an expansive regulatory framework, rather than restrictive ones. This case involved the FDAMA prohibition on soliciting prescriptions for and advertising for compounded drugs. These restrictions on the dissemination of information regarding compounding of medications were found to have unconstitutional restrictions on commercial speech. Tommy G. Thompson v. Western States Medical Center. 535 U.S. 357; 122 S. Ct. 1497; 152 L. Ed. 2d 563 (2002) applying the schema of Central Hudson Gas & Elec. Corp. v. Public Serv. Comm’n of N. Y., 447 U.S. 557, 566, 65 L. Ed. 2d 341, 100 S. Ct. 2343.
While Washington and Western are cases applying the First Amendment, they demonstrate that FDA and its medication regulation are issues within the purview of the courts — even if the regulations involve health and safety issues.
Raising Issues
The issues I have addressed remain open; their consideration is ongoing. However, iPLEDGE is now the law. I must concede that I know only the healing powers of isotretinoin. I have never had a patient nor spoken to a doctor who had a patient with a baby with birth defects caused by isotretinoin. I hope I never do, and my heart goes out to those who have suffered.
I believe that the people who advise and head the FDA and the advocates of isotretinoin restriction, such as Representative Stupak (whose son was taking isotretinoin at the time when he committed suicide), profoundly and sincerely believe that their actions in regard to isotretinoin enhance Americans’ general welfare and commonweal. I admire the fervor of their work and convictions in this regard.
Patients and doctors do not have to surrender their common sense or their ideals. Patients and physicians are not without a political voice or a means of legal recourse when they believe they are legally ill-served and beset. The laws and regulations that rule America are not immutable. Rather, they are a process in constant evolution.
Patients and physicians must decide if they believe they should accept iPLEDGE. It is also possible that the iPLEDGE legal schema is not legally sound. The legal soundness of iPLEDGE is something patients and physicians should consider and reconsider and address judicially and politically if they view it as legally unsound or unjust. They are entitled, and some would say obliged, to ask the courts in reference to the actions of the FDA regarding iPLEDGE Sed quis custodiet ipsos custodes? (Who Will Watch the Watchmen?)
If you and your patients have been suffering under the onerous iPLEDGE program, then you and your patients may be wondering how all of this will ultimately sort out. Although I don’t claim to have any hard-and-fast answers, I have been considering some legal bases to challenge iPLEDGE.
In this article, I’ll discuss some of these possible challenges to iPLEDGE. However, I must first offer the caveat that although I went to law school and am a member of the New York State Bar, I practice dermatology and not law. Whether my legal review is sound or viable or can provide a basis to effect change, I can only speculate and will leave for others to judge.
Born of Good Intentions
I believe that those who want to restrict the use of isotretinoin (Accutane, Amnesteem, Claravis, Sotret) believe that they are doing good. The members of March of Dimes are weary of marching; they don’t want to see any babies with birth defects in their time. For them, iPLEDGE is one more puzzle wedge pushed in against another puzzle wedge, and when all the wedges are apposed a world free from pathologic congenital abnormalities will appear.
The moment of an abortion is an unhappy moment from every angle, but a different understanding of the consequences of abortion as it relates to personal and societal happiness separates those who are pro-life from those who are pro-choice. Pro-life and pro-choice partisans undoubtedly agree that every moment spent under the mask of disfiguring acne is an unhappy moment and even a continual torment. They might only differ on the implications of therapeutic options that free patients from acne’s scarring effects.
Looking More Carefully at the Legality of iPLEDGE
The following regulation brought iPLEDGE into effect: 21 Code of Federal Regulations 314, Subpart H.
When considering the legal basis for challenging iPLEDGE, it is important to note that there is no federal right to healthcare in the United States. Harris v. McRae. 448 U.S. 297 (1980) (“states participating in the Medicaid program were not obligated to fund medically necessary abortions under Title XIX”).
Patients’ Bill of Rights
Some states, however, have in effect a patients’ bill of rights (e.g. 381.026 Florida Patient’s Bill of Rights and Responsibilities).
While federal law typically preempts state law, this does not mean that a federal law or regulation cannot be challenged under a state law. Even though the courts always show great deference to the FDA, in matters protecting public safety, if patients as plaintiffs can adduce evidence that a state’s patients’ bill of rights is being violated by iPLEDGE, a cause of action challenging the existence of iPLEDGE could be brought, although it might not succeed.
If no viable cause of action can be founded under a state’s patients’ bill of rights, then perhaps the advocates for a federal “patients’ bill of rights” might find additional advocates and support for their cause. If Congress enacts a federal “patients’ bill of rights”, this might allow patients to challenge iPLEDGE as an obstruction of their access to care. A way to counteract regulatory fait is to accord those who are subject to regulation a legal right to challenge the regulation that affects them.
The iPLEDGE system virtually and in reality denies isotretinoin to certain specific (and some possibly could say protected) classes of persons in the United States. The constitution affords “equal protection” to all U.S. inhabitants. Persons in prison (a group of 1 to
1.5 million Americans) do not have ready (and often any) access to computers and to phones. Without a phone or an Internet connection, a patient who happens to be incarcerated can not obtain isotretinoin under any circumstances as iPLEDGE stands.
This lack of access to phones (except for family and legal matters) and computers is founded (I am convinced wholly correctly) on protecting public safety. I defer to the prison authorities and courts in this regard. However, an advocate for public health could find iPLEDGE immiscible to public health and favor a prisoner’s access to isotretinoin and, at the same time, not want the prisoner to have access to phones or the Internet in a fashion that is not consistent with good penal practice.
As such, an interested party could challenge iPLEDGE on the basis of a denial of equal protection. In passing, I should note that in Goodman & United States v. Georgia 546 US ___ (2006), the Supreme Court found that the Americans with Disabilities Act protects people held in a state prison from discrimination by prison officials. Perhaps someone might take up the cause of defending prisoners against FDA regulations with which the prisoners cannot comply — and in so doing reveal the contradictions of the iPLEDGE system.
Americans with Disabilities
Taking this idea further, might not persons with nodulocystic acne be considered to be “a protected class,” under the Americans with Disability’s Act as identifiable persons who suffer from discrimination and disability?
Cunliffe, in his article titled “Acne and unemployment” (Br J Dermatol. 1986 Sep;115(3):386.), noted that persons with severe acne have a much higher rate of unemployment than those with clear, acne-free skin. Disfiguring acne is a visible stigma that cannot be hidden.
The Supreme Courts has mandated that public facilities accommodate those who have disabilities; however, the courts have not required that those with disabilities accommodate themselves to political considerations.
If a plaintiff under the Americans with Disability’s Act, with severe disabling nodulocystic acne made a claim that iPLEDGE resulted in an inhibition in his or her ability to obtain isotretinoin, a legally approved medication, needed to cure his or her disease or a denial of medical care, might not iPLEDGE at least be challenged, delayed, reworked or reconsidered?
STEPS Is Not a Good Model for iPLEDGE
The use of inapposite regulatory analogs should prompt patient and physician concern and possible judicial intervention. The STEPS program, which regulates thalidomide, has been touted as a demonstration of a workable regulatory schema for teratogenic medication control. STEPS is not instructive for the functioning of iPLEDGE. Even though the STEPS program allowed thalidomide to come back to the market in the United States, it was a founded on a legal fiction.
I once asked representatives from Cellgene, the manufacturers of thalidomide, how many cases of erythema nodosum leporsum (for which thalidomide is approved), were in the United States. This was back in 2002, and the company representative ventured a guess of about a dozen patients.
I know that patients with multiple myeloma, lupus and other diseases are prescribed thalidomide — but these amounts of patients are a fraction of the number of patients who suffer from acne. iPLEDGE affects tens of thousands of patients with acne who have had no voice in a system rendered as a regulatory fait a compli.
The Government Can Not Practice Medicine
Although the FDA is empowered by Congress to ensure the safety of medications, it is the duty of the FDA to allow physicians to practice medicine. The legal power of 21 Code of Federal Regulations 314, Subpart H legally reified iPLEDGE. However, a regulation lacks the legal heft that a court might accord a law passed by Congress or a provision of the Constitution and hence is more susceptible to legal challenge.
Part of the intention of the Federal Food Drug and Cosmetic Act of 1938 and the Drug amendments of 1962 was to state that the FDA was not to interfere with the practice of medicine. Congress has repeatedly stated that physicians may prescribe medications for diseases based on their medical judgment, rather than based on the package insert. One could posit that iPLEDGE is legally unsound or at least requires reworking as an interference with the practice of medicine that Congress has expressly forbidden to grant the FDA
in the past. It is possible that a professional association could ask a court (perhaps for declaratory relief) to jive Congress’s legislative direction with the FDA’s dictum.
A Legally Overbroad Program?
iPLEDGE might also be considered to be legally overbroad, even by a court showing deference to the special expertise of FDA and its regulatory panels and advisory boards. While narcotics, which are addictive and potentially fatal, merit close monitoring, it is hard to understand a legally sound regulatory framework in which isotretinoin is monitored even more closely than narcotics.
If a Jehovah’s witness can refuse a transfusion, then why can’t a patient, for the sake of argument on religious grounds, refuse to be made to choose abstinence or contraception in order to receive the medically established care they desire?
The iPLEDGE system treats lifesaving isotretinoin as it does isotretinoin for acne. Isotretinoin is lifesaving for neuroblastoma, a fast growing cancer in children. iPLEDGE might impede its prescription and utilization for treatment of this killer cancer. If iPLEDGE halts the use of isotretinoin for 1 day, in one child, or steals 1 day of life, then the parent of such a child might have grounds to legally challenge iPLEDGE as overburdensome or overbroad.
FDA Is Not Invincible
The FDA is not like the “invincible Jupiter” — a god of the Romans who could not know retreat. Numerous groups have challenged regulations proposed or implemented by the FDA and had the FDA’s regulations amended or appended.
This was the case in Washington Legal Foundation v. Friedman. The FDA tried to limit the dissemination of “off-label” information. A district court rebuffed the FDA’s actions. The FDA appealed a district court decision holding that the Food and Drug Administration Modernization Act of 1997 (FDAMA), which established procedures by which drug and medical device manufacturers could disseminate information about “off-label” uses for their products, violated the First Amendment.
In the end, the FDA admitted that the statute did not provide it with independent authority to proscribe speech, and the case ended. Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998); Washington Legal Foundation v. Friedman, 56 F. Supp. 2d 81 (D.D.C. 1999) dismissed, 202 F.3d 331 (DC. Cir. 2000).
Another First Amendment case challenging the FDA involved pharmaceutical regulations that were cast to provide an expansive regulatory framework, rather than restrictive ones. This case involved the FDAMA prohibition on soliciting prescriptions for and advertising for compounded drugs. These restrictions on the dissemination of information regarding compounding of medications were found to have unconstitutional restrictions on commercial speech. Tommy G. Thompson v. Western States Medical Center. 535 U.S. 357; 122 S. Ct. 1497; 152 L. Ed. 2d 563 (2002) applying the schema of Central Hudson Gas & Elec. Corp. v. Public Serv. Comm’n of N. Y., 447 U.S. 557, 566, 65 L. Ed. 2d 341, 100 S. Ct. 2343.
While Washington and Western are cases applying the First Amendment, they demonstrate that FDA and its medication regulation are issues within the purview of the courts — even if the regulations involve health and safety issues.
Raising Issues
The issues I have addressed remain open; their consideration is ongoing. However, iPLEDGE is now the law. I must concede that I know only the healing powers of isotretinoin. I have never had a patient nor spoken to a doctor who had a patient with a baby with birth defects caused by isotretinoin. I hope I never do, and my heart goes out to those who have suffered.
I believe that the people who advise and head the FDA and the advocates of isotretinoin restriction, such as Representative Stupak (whose son was taking isotretinoin at the time when he committed suicide), profoundly and sincerely believe that their actions in regard to isotretinoin enhance Americans’ general welfare and commonweal. I admire the fervor of their work and convictions in this regard.
Patients and doctors do not have to surrender their common sense or their ideals. Patients and physicians are not without a political voice or a means of legal recourse when they believe they are legally ill-served and beset. The laws and regulations that rule America are not immutable. Rather, they are a process in constant evolution.
Patients and physicians must decide if they believe they should accept iPLEDGE. It is also possible that the iPLEDGE legal schema is not legally sound. The legal soundness of iPLEDGE is something patients and physicians should consider and reconsider and address judicially and politically if they view it as legally unsound or unjust. They are entitled, and some would say obliged, to ask the courts in reference to the actions of the FDA regarding iPLEDGE Sed quis custodiet ipsos custodes? (Who Will Watch the Watchmen?)
