Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

HHS INSPECTOR GENERAL DRUG-RELATED INITIATIVES PLANNED FOR 1990 & 1991

Executive Summary

The following chart was compiled by "The Pink Sheet" from a draft of the 1990 and 1991 work plan of HHS' Office of the Inspector General. The plan is being revised and programs, particularly those slated for 1991, may be deleted or their time frame changed as other priority investigations and audits come up. Planned dates for the IG programs are given in parentheses; the government's fiscal year (FY) runs from Oct. 1 to Sept. 30. Thus, FY 1990 is the year from Oct. 1, 1989 to Sept. 30, 1990. FDA-RELATED PROJECTS Perspective of drug manufacturers -- Study of drug manufacturers' perspectives on FDA drug approval process (Draft of report on survey results was presented to FDA officials for review on Jan. 9) Generic drug review process -- Evaluation of FDA's policies and procedures for processing and approving generic drug applications (ongoing) Coordination of FDA cases -- Project will implement cooperative investigative efforts with FDA in areas of mutual interest, with special emphasis on scientific misconduct and clinical investigator cases (ongoing) Adverse drug reaction reporting system -- Assessment of the adequacy of direct physician and pharmacist reporting and problems tied to mandatory manufacturer reporting (third quarter FY 1990) Direct-to-consumer prescription drug advertising -- Analysis of the range and nature of prescription drug advertising, its effect on consumers, and its effect on drug pricing (second quarter FY 1991) Orphan Drug Act -- Assessment of whether necessary clinical and nonclinical investigations have been conducted prior to approving a product as an orphan drug (fourth quarter 1991) Timely analysis of product samples -- Assess actions taken to respond to a prior General Accounting Office report that laboratory analysis of product samples needs to be more timely (fourth quarter FY 1991) REIMBURSEMENT/FUNDING & COST-RELATED PROJECTS Implementation of Medicaid regs -- Review of states' compliance with reg's upper limit aggregates for multiple-source drugs and whether savings are being achieved (second quarter FY 1990) Medicaid multi-source additions -- Assessment of whether current upper limit list for Medicaid should be expanded (second quarter FY 1990) Medicaid payment for less-than-effective drugs -- Review of at least 28 states to determine if they are making payments for less-than-effective drugs (second quarter FY 1990) Federal vaccine compensation liability -- Assessment of the impact of the vaccine compensation liability program on the cost and availability of vaccines; the cost of federal and state vaccination programs; and the compensation available to injured claimants (third quarter FY 1990) AZT funding -- Review of adequacy of current funding for AZT and whether available funds are being expended appropriately and efficiently (fourth quarter FY 1990) Erythropoietin -- Examination of utilization and pricing issues raised by Medicare use of erythropoietin (fourth quarter FY 1990) Reimbursement for parenteral & enteral therapies -- Review Medicare payment procedures for parenteral and enteral therapies to see if savings can be achieved if notice of beneficiary absences from nursing homes are provided to the carrier (second quarter FY 1991) Cost of health care for AIDS patients -- Identify inefficiencies causing problems in financing AIDS patient treatment programs (fourth quarter FY 1991) Prescription drug reimbursements -- Assessment of whether federal government is taking advantage of available savings in its procurement of prescription drugs for Medicaid (fourth quarter FY 1991) ETHICS, MISCONDUCT & INTERNAL CONTROLS Pharmacy fraud in Medicaid -- Several projects attempting to obtain convictions and restitution from pharmacies that have overbilled, falsely billed or committed other violations involving the Medicaid program (ongoing) Scientific misconduct in research grants -- Identification of potential criminal violations in grants funded by Public Health Service agencies (ongoing) Intramural clinical research -- Review of adequacy of NIH controls to prevent conflict of interest in clinical trials (third quarter FY 1990) Ethics and integrity in government -- Education program on integrity matters, with emphasis on bribery awareness, conflict of interest and noncriminal misconduct. Program will begin with FDA (fourth quarter FY 1990) OTHER RESEARCH & DRUG-RELATED PROJECTS Illegal distribution of drugs -- Obtain criminal and civil convictions and administrative actions against individuals and firms involved in counterfeiting, diversion, and illegal distribution of steroids (ongoing) Technology transfer (intramural) -- Evaluation of the adequacy of controls over transfer of technology and whether government is collecting the maximum amount of royalty income (second quarter FY 1990) Clinical trials -- Inspection will ascertain potential weaknesses in medical monitoring system for drug studies (third quarter FY 1990) Adverse drug reactions in the elderly -- Study of prevalence and types of ADRs to drugs commonly given to the elderly (third quarter FY 1990)

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

MT101489

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel