[Source: Peter Baron Hutt, The Transformation of United States Food and Drug Law, J. Ass'n Food & Drug Officials, Sept. 1996, at 1 (reprinted in Law, Medicine, and Medical Technology, Noah et al., at 70 (2002)]
Neither the 1906 Act nor the 1938 Act is self-executing. Both have required FDA to implement very broad and general statutory provisions with more specific operating rules. Thus, FDA has spent the past century determining, and then making public, procedural and substantive policy statements designed to facilitate its administration of the organic statute.
Prior to the 1970s, it was common practice simply to propose a regulation, obtain public comment and then publish a final regulation, without an explanation of the reasons for the proposal or why the changes recommended by the public comment were or were not accepted in the final regulations. FDA pioneered the use of explanatory preambles to both the proposed and the final regulations. These preambles served and continue to serve to this day the purpose of educating FDA employees, the regulated industry and the general public about the importan work of the agency. Today Congress requires all federal agencies to justify their rulemaking.
Under the 1906 Act, any violation constituteed a misdemeanor punishable by a fine, imprisonment or both. Violative products were also subject to seizure. The 1938 Act expanded FDA's enforcement power. In addition to criminal liability and seizure, FDA was authorized to obtain a judicial injunction against any violation of the statute. FDA was also authorized to issue a written administrative notice or warning for minor violations in lieu of formal court proceedings, to conduct factory inspection and to issue publicity and other public information. As the 1938 Act was amended to require premarket approval for regulated products, FDA was able to enforce the statute informally through administrative decisions as part of the approval process rather than by formal court action.
From a policing role under the 1906 Act, FDA gradually undertook the role of sole gatekeeper to the marketplace. For a product subject to premarket approval, no manufacturer may lawfully distribute the product and no member of the public has a right to obtain it unless and until FDA authorizes marketing.
Premarket approval under the 1938 Act includes no mechanism for public accountability. Citizens who wish to obtain a product have no right to participate in the process and no access to judicial review of whatever action is taken by FDA. Even the applicant is precluded from access to the courts until final action is taken on a product application.
Thursday, August 2, 2007
FDA Regulations and Dietary Supplements
In 1994, Congress enacted the Dietary Supplement Health and Education Act (DSHEA), Pub. L. No. 103-417, 108 Stat. 4325, in order to limit tha FDA's power to regulate dietary supplements as either food additives or new drugs.
In an enforcement proceeding alleging that a dietary supplement is adulterated, the FDA now shoulders the burden of proving that it "presents a significant or unreasonable risk of illness or injury." 21 U.S.C. § 342(f)(1)(A). A company wishing to sell a supplement containing a "new dietary ingredient" (defined as one not marketed before October 15, 1994) must file a notification with the FDA 75 days prior to market introduction, which would have to demonstrate only that "[t]here is a history of use or other evidence of safety," id. § 350b(a)(2), but, if the agency found the notification inadequate, it could prevent marketing only by initiating formal enforcement proceedings. The term "dietary supplement" means a product "intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botantical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described" above. Id. § 321 (ff)(1).
In an enforcement proceeding alleging that a dietary supplement is adulterated, the FDA now shoulders the burden of proving that it "presents a significant or unreasonable risk of illness or injury." 21 U.S.C. § 342(f)(1)(A). A company wishing to sell a supplement containing a "new dietary ingredient" (defined as one not marketed before October 15, 1994) must file a notification with the FDA 75 days prior to market introduction, which would have to demonstrate only that "[t]here is a history of use or other evidence of safety," id. § 350b(a)(2), but, if the agency found the notification inadequate, it could prevent marketing only by initiating formal enforcement proceedings. The term "dietary supplement" means a product "intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botantical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described" above. Id. § 321 (ff)(1).
A product is regulated according to claims made for it rather than its composition
See S. Rep. No. 73-493, at 2-3 (1934) ("The use to which a product is put will determine the category into which it will fall . . . . The manufacturer of this article, through his representations in connection with its sale, can determine the use to whcih an article is to be put."). The mere presence of a chemically active substance would not satisfy this definition; the intended use of the substance must serve a diagnostic or therapeutic purpose or otherwise affect the structure or function of the body. Conversely, a chemically inert substance can qualify as a drug depending on the claims made for it. Thus, bottled water, which would normally be regulated by FDA as a food (and also by the EPA under a different statute) might be regulated (1) as a drug if labeled as a cure for cancer, (2) as a medical device (accessory) if labeled as a sterilizing agent for surgical instruments, or (3) as a cosmetic if labeled as a skin softener. See Bradley v. United States, 264 F. 79, 81-82 (5th Cir. 1920) (holding that curative claims for mineral water made it a "drug").
The intended use of a product typically is determined by its labeling and any other promotional claims made by the seller. See, e.g., United States v. Article of Drug . . . B-Complex Cholinos Capsules, 362 F.2d 923, 925-26 (3d Cir. 1966) (radio broadcasts); Nature Food Centres, Inc. v. United States, 310 F.2d 67, 70 (1st Cir. 1962) (public lectures); V.E. Irons, Inc. v. United States, 244 F.2d 34, 44 (1st Cir. 1957) (oral representations made by authorized sales distributors).
More controversially, the FDA has suggested that "intended use" may include the seller's subjective intent even if never communicated to consumers, which would mean that promotional claims provide the best but no exclusive evidence of a product's intended use. See Richard M. Cooper, The WLF Case Thus Far, 55 Food & Drug L.J. 477, 485-86 (2000) (criticizing this interpretation); see also Meza v. Southern Cal. Physicians Ins. Exchange, 73 Cal.Rptr.2d 91, 94 (Ct. App. 1998) (concluding that melaleuca oil used by a physician to treat warts qualified as a drug even though the seller made no therapeutic claims).
The intended use of a product typically is determined by its labeling and any other promotional claims made by the seller. See, e.g., United States v. Article of Drug . . . B-Complex Cholinos Capsules, 362 F.2d 923, 925-26 (3d Cir. 1966) (radio broadcasts); Nature Food Centres, Inc. v. United States, 310 F.2d 67, 70 (1st Cir. 1962) (public lectures); V.E. Irons, Inc. v. United States, 244 F.2d 34, 44 (1st Cir. 1957) (oral representations made by authorized sales distributors).
More controversially, the FDA has suggested that "intended use" may include the seller's subjective intent even if never communicated to consumers, which would mean that promotional claims provide the best but no exclusive evidence of a product's intended use. See Richard M. Cooper, The WLF Case Thus Far, 55 Food & Drug L.J. 477, 485-86 (2000) (criticizing this interpretation); see also Meza v. Southern Cal. Physicians Ins. Exchange, 73 Cal.Rptr.2d 91, 94 (Ct. App. 1998) (concluding that melaleuca oil used by a physician to treat warts qualified as a drug even though the seller made no therapeutic claims).
CMS- Medicare Program; Revised Payment System Policies for Services Furnished in Ambulatory Surgical Centers (ASCs) Beginning in CY 2008 - Final Rule
[72 Fed. Reg. 148, 42470-42626 (Aug. 2, 2007) (42 CFR Parts 410 and 416)]
This final rule revises the Medicare ambulatory surgical center (ASC) payment system to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). This final rule establishes the ASC list of covered surgical procedures, identifies covered ancillary services under the revised ASC payment system, and sets forth the amounts and factors that will be used to determine the ASC payment rates for calendar year (CY) 2008. The changes to the ASC payment system and ratesetting methodology in this final rule are applicable to services furnished on or after January 1, 2008.
This final rule revises the Medicare ambulatory surgical center (ASC) payment system to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). This final rule establishes the ASC list of covered surgical procedures, identifies covered ancillary services under the revised ASC payment system, and sets forth the amounts and factors that will be used to determine the ASC payment rates for calendar year (CY) 2008. The changes to the ASC payment system and ratesetting methodology in this final rule are applicable to services furnished on or after January 1, 2008.
CMS - Medicare Program: Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Payment Rates...
[72 Fed. Reg. 148, 42627-43130 (Aug. 2, 2007) (42 CFR Parts 410, 411, 414 et al.)]
This proposed rule would revise the Medicare hospital outpatient prospective payment system (PPS) to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes would be applicable to services furnished on or after January 1, 2008. In addition, this proposed rule would update the revised Medicare ambulatory surgical center (ASC) payment system to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). In this proposed rule, we propose the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which the final policies of the ASC payment system would apply, and other pertinent ratesetting information for the CY 2008 ASC payment system.
These changes would be applicable to services furnished on or after January 1, 2008. In this proposed rule, we also are proposing changes to the policies relating to the necessary provider
designations of critical access hospitals (CAHs) that are being recertified when a CAH enters into a new co-location arrangement with another hospital or CAH or when the CAH creates or acquires an off-campus location.
Further, we are proposing changes to several of the current conditions of participation that hospitals must meet to participate in the Medicare and Medicaid programs to require the completion and documentation in the medical record of medical histories and physical examinations of patients conducted after admission and prior to surgery or a procedure requiring anesthesia services and for postanesthesia evaluations of patients before discharge or transfer from the postanesthesia recovery area.
****
Notes:
Prospective reimbursement, especially once adopted by Medicare in 1983, marked an important turning point in regulatory efforts to contain the growth of hospital costs. Medicare's Prospective Payment System (PPS) limits hospital revenues per Medicare patient. Under PPS, hospitals are reimbursed a fixed amount per admission, determined by the patient's diagnostic condition (Diagnostic Related Groups), regardless of the hospital's actual costs. The strategy behind PPS is simple. By limiting revenues, it provides hospitals with strong disincentives to extend lengths of stay and provide unnecessary or marginal care.
Medicare's payment system can be grouped as follows:
This proposed rule would revise the Medicare hospital outpatient prospective payment system (PPS) to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes would be applicable to services furnished on or after January 1, 2008. In addition, this proposed rule would update the revised Medicare ambulatory surgical center (ASC) payment system to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). In this proposed rule, we propose the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which the final policies of the ASC payment system would apply, and other pertinent ratesetting information for the CY 2008 ASC payment system.
These changes would be applicable to services furnished on or after January 1, 2008. In this proposed rule, we also are proposing changes to the policies relating to the necessary provider
designations of critical access hospitals (CAHs) that are being recertified when a CAH enters into a new co-location arrangement with another hospital or CAH or when the CAH creates or acquires an off-campus location.
Further, we are proposing changes to several of the current conditions of participation that hospitals must meet to participate in the Medicare and Medicaid programs to require the completion and documentation in the medical record of medical histories and physical examinations of patients conducted after admission and prior to surgery or a procedure requiring anesthesia services and for postanesthesia evaluations of patients before discharge or transfer from the postanesthesia recovery area.
****
Notes:
Prospective reimbursement, especially once adopted by Medicare in 1983, marked an important turning point in regulatory efforts to contain the growth of hospital costs. Medicare's Prospective Payment System (PPS) limits hospital revenues per Medicare patient. Under PPS, hospitals are reimbursed a fixed amount per admission, determined by the patient's diagnostic condition (Diagnostic Related Groups), regardless of the hospital's actual costs. The strategy behind PPS is simple. By limiting revenues, it provides hospitals with strong disincentives to extend lengths of stay and provide unnecessary or marginal care.
Medicare's payment system can be grouped as follows:
- Inpatient acute care in short-term hospitals annd psychiatric facilities
- Ambulatory care furnished by physicians, hospital outpatient departments, ambulatory surgical centers, and clinical laboratories
- Post-acute care furnished by skilled nursing facilities, home health agencies, inpatient rehabilitation facilities, and long-term care hospitals
- Dialysis services furnished in outpatient centers and hospice care
- Ambulance services and products furnished by durable medical equipment suppliers
- Services furnished by private health plans under the Medicare+Choice (M+C) program
DRGs define one of the primary mechanisms for prospective payment. Under PPS, patients are admitted according to their condition under one of 506 applicable DRGs. Each DRG attempts to represent a case type that identifies patients with similar conditions and processes of care.
Each DRG is given a flat payment rate calculated in part on the basis of costs incurred for that DRG nationally. These rates are modified somewhat in practice to account for differences in local wages, urban versus rural location, and other factors such as whether the hospital is a teaching hospital. The rates are flat in the important sense that they are not varied or softened for hospitals that spend more than the rate, or for that matter less.
Electrical Pulses Revive Man Years After Mugging
[Source: WSJ Health Blog, Jacob Goldstein]
A 38-year-old man who had been in a coma-like state for eight years regained consciousness after doctors stuck electrodes deep into his brain and flipped the switch, according to a letter published in the journal Nature
Just hours after the treatment with electrical pulses began last year, the unnamed man opened his eyes and began tracking movement in his room. Over the following months, he regained the ability to speak in short sentences, drink from a cup and comb his hair, the Los Angeles Times reports. “Now he can cry and laugh and say ‘Mommy’ and ‘Pop,’ ” his mother said at a news conference.
The man was severely injured during a mugging, when he was repeatedly kicked in the head. He was left in a minimally conscious state, in which a patient shows occasional signs of awareness but can’t communicate.
In the technique, known as deep brain stimulation and sometimes used on Parkinson’s patients, electrodes are inserted into the thalamus, which controls arousal. Doctors hope this case will be the first in a series of 12 patients to test whether the results can be reproduced. They chose the patient because they believed the arousal system in his thalamus was damaged, but that key areas of the cerebral cortex were undamaged.
A 38-year-old man who had been in a coma-like state for eight years regained consciousness after doctors stuck electrodes deep into his brain and flipped the switch, according to a letter published in the journal Nature
Just hours after the treatment with electrical pulses began last year, the unnamed man opened his eyes and began tracking movement in his room. Over the following months, he regained the ability to speak in short sentences, drink from a cup and comb his hair, the Los Angeles Times reports. “Now he can cry and laugh and say ‘Mommy’ and ‘Pop,’ ” his mother said at a news conference.
The man was severely injured during a mugging, when he was repeatedly kicked in the head. He was left in a minimally conscious state, in which a patient shows occasional signs of awareness but can’t communicate.
In the technique, known as deep brain stimulation and sometimes used on Parkinson’s patients, electrodes are inserted into the thalamus, which controls arousal. Doctors hope this case will be the first in a series of 12 patients to test whether the results can be reproduced. They chose the patient because they believed the arousal system in his thalamus was damaged, but that key areas of the cerebral cortex were undamaged.
U.S. Senate panel votes to allow FDA regulation of tobacco products.
[Source: The Health and Life Sciences Law Daily, August 2, 2007]
The CBS Evening News (8/1, lead story, 2:30, Couric) reported, "A Senate committee today approved legislation that would for the first time regulate the tobacco companies. Despite all the health warnings, more than 45 million Americans still smoke. And, every year more than 400,000 die of smoking-related illnesses. Supporters of the legislation say it would cut those deaths dramatically."
The AP (8/2, Jalonick) reports, "The bill, approved 13-8 by the Health, Education, Labor and Pensions Committee, would give the Food and Drug Administration authority to restrict tobacco advertising, regulate warning labels, and remove hazardous ingredients." The agency would also "be given the authority to set standards for products that tobacco companies advertise as 'reduced risk' products."
The Boston Globe (8/2, Henderson) reports that the legislation, sponsored by Senator Edward M. Kennedy (D-Mass.), "was the result of years of negotiations that forged an unlikely coalition uniting dozens of health groups with the tobacco giant Philip Morris." While the "FDA currently can regulate such nicotine-replacement products as gums and patches," it "lacks regulatory oversight over cigarettes and smokeless tobacco." Sen. Kennedy noted, "With all the provisions we have in the tobacco bill, we have a real opportunity to save a generation of Americans from a lifetime of addiction and certain death." Meanwhile, Wyoming Senator Michael B. Enzi, the highest-ranking Republican on the Senate Health, Education, Labor and Pensions Committee, "denounced the bill as 'fundamentally flawed' and said it merely locks in place Philip Morris's dominant market share." Enzi noted, "If this bill is good for Big Tobacco, how can it be good for public health? ... The fact is it can't. This bill is nothing more than a Marlboro Protection Act." Philip Morris USA, manufacturer of Marlboro, "supports the bill, a stance at odds with industry rivals and companies that manufacture smokeless tobacco." The Wall Street Journal (8/2, A4) also covers the story.
[S. 625 / H.R. 1108]
The CBS Evening News (8/1, lead story, 2:30, Couric) reported, "A Senate committee today approved legislation that would for the first time regulate the tobacco companies. Despite all the health warnings, more than 45 million Americans still smoke. And, every year more than 400,000 die of smoking-related illnesses. Supporters of the legislation say it would cut those deaths dramatically."
The AP (8/2, Jalonick) reports, "The bill, approved 13-8 by the Health, Education, Labor and Pensions Committee, would give the Food and Drug Administration authority to restrict tobacco advertising, regulate warning labels, and remove hazardous ingredients." The agency would also "be given the authority to set standards for products that tobacco companies advertise as 'reduced risk' products."
The Boston Globe (8/2, Henderson) reports that the legislation, sponsored by Senator Edward M. Kennedy (D-Mass.), "was the result of years of negotiations that forged an unlikely coalition uniting dozens of health groups with the tobacco giant Philip Morris." While the "FDA currently can regulate such nicotine-replacement products as gums and patches," it "lacks regulatory oversight over cigarettes and smokeless tobacco." Sen. Kennedy noted, "With all the provisions we have in the tobacco bill, we have a real opportunity to save a generation of Americans from a lifetime of addiction and certain death." Meanwhile, Wyoming Senator Michael B. Enzi, the highest-ranking Republican on the Senate Health, Education, Labor and Pensions Committee, "denounced the bill as 'fundamentally flawed' and said it merely locks in place Philip Morris's dominant market share." Enzi noted, "If this bill is good for Big Tobacco, how can it be good for public health? ... The fact is it can't. This bill is nothing more than a Marlboro Protection Act." Philip Morris USA, manufacturer of Marlboro, "supports the bill, a stance at odds with industry rivals and companies that manufacture smokeless tobacco." The Wall Street Journal (8/2, A4) also covers the story.
[S. 625 / H.R. 1108]
Sen. Cardin introduces legislation mandating health insurance for all.
[Source: The Health and Life Sciences Law Daily, August 1, 2007]
Modern Healthcare (8/1, Lubeli) reports, "Sen. Benjamin Cardin (D-Md.) has introduced legislation that would require all Americans to enroll in a healthcare insurance plan." Americans lacking coverage "would have to enroll in a 'qualified' plan such as Medicare, Medicaid, the State Children's Health Insurance Program (SCHIP), veterans' healthcare, federal health employee benefits or other state-approved package." Cardin, who is on the Senate Budget Committee, noted, "Today, more than 46 million Americans, including 9 million children, have no healthcare coverage. We all pay the price with either higher premium costs or more expensive medical bills. ... This legislation provides a simple, straight-forward solution that will ensure that all Americans have health insurance." For "individuals below 400% of the federal poverty level, the bill would offer three low-cost coverage options." As for penalties, those "who failed to enroll for any coverage for a continuous period greater than 60 days would be taxed, and the funds collected by this tax would then be used to automatically enroll them in a state-approved plan, according to a summary of the bill."
[S. 1899: A Bill to Require Every American to Have Health Insurance Coverage]
Modern Healthcare (8/1, Lubeli) reports, "Sen. Benjamin Cardin (D-Md.) has introduced legislation that would require all Americans to enroll in a healthcare insurance plan." Americans lacking coverage "would have to enroll in a 'qualified' plan such as Medicare, Medicaid, the State Children's Health Insurance Program (SCHIP), veterans' healthcare, federal health employee benefits or other state-approved package." Cardin, who is on the Senate Budget Committee, noted, "Today, more than 46 million Americans, including 9 million children, have no healthcare coverage. We all pay the price with either higher premium costs or more expensive medical bills. ... This legislation provides a simple, straight-forward solution that will ensure that all Americans have health insurance." For "individuals below 400% of the federal poverty level, the bill would offer three low-cost coverage options." As for penalties, those "who failed to enroll for any coverage for a continuous period greater than 60 days would be taxed, and the funds collected by this tax would then be used to automatically enroll them in a state-approved plan, according to a summary of the bill."
[S. 1899: A Bill to Require Every American to Have Health Insurance Coverage]
Patient-advocacy group files lawsuit against FDA alleging faulty drug review.
[Source: Health and Life Sciences Law Daily, August 1, 2007]
The Seattle Times (8/1, Gonzalez) reports, "A patient-advocacy group sued U.S. Food and Drug Administration officials Monday for withholding approval" of Dendreon's Provenge (sipuleucel-T) in May. The plaintiffs "say the spurned drug is safe and effective, and claim the denial was the capricious outcome of political infighting within the agency. The lawsuit (pdf), filed by Dublin, Ohio-based nonprofit Care to Live in federal court in Columbus, also accuses the agency of ignoring conflict-of-interest issues with some medical advisers chosen to review the therapy."
BusinessWeek (8/1, Arnst) reports that the lawsuit "marks the latest salvo in an acrimonious campaign to gain access to the Dendreon vaccine after the FDA concluded in May that existing data did not warrant approval." The lawsuit names FDA Commissioner Dr. Andrew von Eschenbach, HHS Secretary Michael Leavitt, and Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products. Also named is "Dr. Howard Scher, one of the four members of the FDA advisory panel to vote against recommending Provenge for approval." The "Care To Live suit follows a more sweeping action taken by another patient advocacy group, the Abigail Alliance for Better Access to Developmental Drugs, which is suing for broader access to experimental drugs. That lawsuit is currently being considered by the federal circuit court in Washington, D.C," and if the "Abigail Alliance prevails, it could establish a constitutional right to experimental drugs."
The Seattle Times (8/1, Gonzalez) reports, "A patient-advocacy group sued U.S. Food and Drug Administration officials Monday for withholding approval" of Dendreon's Provenge (sipuleucel-T) in May. The plaintiffs "say the spurned drug is safe and effective, and claim the denial was the capricious outcome of political infighting within the agency. The lawsuit (pdf), filed by Dublin, Ohio-based nonprofit Care to Live in federal court in Columbus, also accuses the agency of ignoring conflict-of-interest issues with some medical advisers chosen to review the therapy."
BusinessWeek (8/1, Arnst) reports that the lawsuit "marks the latest salvo in an acrimonious campaign to gain access to the Dendreon vaccine after the FDA concluded in May that existing data did not warrant approval." The lawsuit names FDA Commissioner Dr. Andrew von Eschenbach, HHS Secretary Michael Leavitt, and Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products. Also named is "Dr. Howard Scher, one of the four members of the FDA advisory panel to vote against recommending Provenge for approval." The "Care To Live suit follows a more sweeping action taken by another patient advocacy group, the Abigail Alliance for Better Access to Developmental Drugs, which is suing for broader access to experimental drugs. That lawsuit is currently being considered by the federal circuit court in Washington, D.C," and if the "Abigail Alliance prevails, it could establish a constitutional right to experimental drugs."
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