Legislative and Administrative Updates
FDA Proposes Amendments for Labeling of Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use
U.S. Government Branch: Department of Health and Human Service. Food and Drug Administration
Title: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling
Summary: The Food and Drug Administration (FDA) is proposing to amend its over-the-counter (OTC) labeling regulations and the tentative final monograph (TFM) for OTC internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include new warnings and other labeling requirements advising consumers about potential risks and when to consult a doctor. FDA is also proposing to remove the alcohol warning in its regulations and add new warnings and other labeling for all OTC IAAA drug products. The new labeling would be required for all OTC drug products containing an IAAA active ingredient whether marketed under an OTC drug monograph or an approved new drug application (NDA). FDA is issuing this proposal as part of its ongoing review of OTC drug products after considering the advice of its Nonprescription Drugs Advisory Committee (NDAC) and other available information. FDA is proposing these labeling changes because it has tentatively concluded they are necessary for these ingredients to be considered generally recognized as safe and effective and not misbranded for OTC use. FDA will address information about the cardiovascular risks of nonsteroidal anti-inflammatory drugs (NSAIDs) that was discussed at a February 16-18, 2005, FDA advisory committee meeting, and the "Allergy alert" warning for NSAID products, in a future issue of the Federal Register.
Status: Proposed regulations printed in Federal Register on December 26, 2006
Notes: Submit written or electronic comments, including comments on FDA's economic impact determination, by May 25, 2007. The specified comment period is longer than is normally provided for proposed rules. Because of the complexity of the proposed rule, FDA is providing an additional 60 days (beyond the normal comment period) for comments to be submitted and does not plan to extend the comment period beyond this date. Please see section XV of this document for the proposed effective and compliance dates of any final rule that may publish based on this proposal. Federal Register: December 26, 2006
FDA Proposes Expanded Access to Investigational Drugs for Treatment Use
U.S. Government Branch: Department of Health and Human Services. Food and Drug Administration
Title: Expanded Access to Investigational Drugs for Treatment Use
Summary: The Food and Drug Administration (FDA) is proposing to amend its regulations on access to investigational new drugs for the treatment of patients. The proposed rule would clarify existing regulations and add new types of expanded access for treatment use. Under the proposal, expanded access to investigational drugs for treatment use would be available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The proposed rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions, who lack other therapeutic options and who may benefit from such therapies.
Note: The "serious disease or condition" requirement refers to conditions that have an important effect on functioning (e.g., stroke, schizophrenia, rheumatoid arthritis, osteoarthritis) or on other aspects of quality of life (e.g., chronic depression, seizures). Alzheimer's dementia, Amyotrophic Lateral Sclerosis (ALS), and narcolepsy are specific examples of serious conditions for which FDA has granted expanded access to investigational drugs in the past. Short-lived and self-limiting morbidity will usually not be sufficient to qualify a condition as serious, but the morbidity need not be irreversible, provided it is persistent or recurrent. Similarly, the proposed requirement here that treatment be for a "serious disease or condition" is not intended to be unnecessarily restrictive. It is primarily intended to exclude ex-panded access to investigational drugs for conditions that are clearly not serious (e.g., symptomatic relief of minor pain or allergic symptoms and other self-limiting conditions not associated with major morbidity).
Status: Submit written or electronic comments by March 14, 2007. Submit written comments on the information collection requirements by January 16, 2007. More Information
Michigan Creates Reflex Sympathetic Dystrophy/Complex Regional Pain Syndrome Workgroup
State: Michigan
Title: House Bill 5603
Summary: Creates reflex sympathetic dystrophy/complex regional pain syndrome workgroup to develop a related education program to promote public awareness of the causes of such syndrome and the value of early detection, diagnosis, and treatment of the disease.
Status: 12/14/2006
House concurred in Senate amendments.
12/14/2006
Ordered Enrolled.
12/27/2006
*****To Governor
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Oklahoma Bill Requires Equal Reimbursement for Chiropractic Services
State: Oklahoma
Title: Senate Bill 19 [Reimbursement for Chiropractic Services]
Summary: Relates to insurance; requires equal reimbursement for chiropractic services; prohibits a higher copayment; provides that an insurer shall not impose as a limitation on treatment or level of coverage a copayment amount charged to the insured for chiropractic services that is higher than the copayment charged to the insured for the services of a duly licenses primary care physician for the same medically necessary treatment or condition; relates to a group policy, hospital plan or medical plan.
Status: 12/14/2006
PREFILED.
Effective Pain Care for Dying Patients Part of Proposed Texas Hospital Licensing Criteria
State: Texas. Department of State Health Services
Title: Title 25. Chapter 133 [Proposed New Hospital Licensing Criteria]
Summary: [Excerpt] §133.42.Patient Rights.
(1) A hospital shall adopt, implement, and enforce a policy to ensure patients' rights. The written policy shall include:
(A) the right of the patient to the hospital's reasonable response to his or her requests and needs for treatment or service, within the hospital's capacity, its stated mission, and applicable law and regulation;
(B) the right of the patient to considerate and respectful care:
(i) the care of the patient includes consideration of the psychosocial, spiritual, and cultural variables that influence the perceptions of illness;
(ii) the care of the dying patient optimizes the comfort and dignity of the patient through:
(I) treating primary and secondary symptoms that respond to treatment as desired by the patient or surrogate decision maker;
(II) effectively managing pain; and
(III) acknowledging the psychosocial and spiritual concerns of the patient and the family regarding dying and the expression of grief by the patient and family;
Status: Proposed date of adoption: February 13, 2007
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