PLAN TO SPEED APPROVAL OF DRUGS: MAKERS WOULD PAY FEES TO U.S

PEDIATRICS ◽  
1993 ◽  
Vol 92 (4) ◽  
pp. 558-558
Author(s):  
J. F. L.
Keyword(s):  
Drug Administration ◽  
Rare Diseases ◽  
Food And Drug Administration ◽  
Drug Industry ◽  
Staff Members ◽  
Life Saving ◽  
Congressional Staff ◽  
The Government ◽  
Biotechnology Products

WASHINGTON, Aug. 10—The Government and the drug industry are near an agreement to require the companies to pay fees that would be used by the Food and Drug Administration to hire 600 new examiners and speed approval of drugs, officials on both sides said today. The agreement, being worked out by Congressional staff members, is intended to resolve what both the Government and industry have said for the last few years is a catastrophe waiting to happen: the number of drug applications is rapidly increasing, especially because of the boom in biotechnology products, some of which might save lives if they were available. But the F.D.A. has not had enough staff members to keep up. Advocates of people with AIDS, cancer and rare diseases have all pressed for quicker approval of potentially life-saving drugs, for time can be crucial in treatment.

SUIT CLAIMS RESEARCH-HOSPITAL DOCTORS SUBMITTED PHONY BILLS TO GET U.S. FUNDS

PEDIATRICS ◽  
1995 ◽  
Vol 96 (5) ◽  
pp. A41-A41
Author(s):  
J. F. L.
Keyword(s):  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
Controversial Issue ◽  
Criminal Investigation ◽  
Research Hospital ◽  
Medical Centers ◽  
Cardiac Procedures ◽  
Hospital Doctors ◽  
The Government

Physicians at dozens of prominent research hospitals nationwide allegedly submitted phony bills and sometimes even falsified patients' records to obtain as much as $1 billion in federal payments for sophisticated, but still experimental, cardiac procedures, a newly unsealed whistleblower suit claims. The allegations of years of systematic fraud involving as many as 130 major medical centers nationwide, accusations that already have prompted a previously reported criminal investigation, are likely to shine a spotlight on the controversial issue of which cutting-edge devices and procedures currently are, or should be, eligible for Medicare or Medicaid claims. Existing regulations say that the government generally won't pay for treatment considered to be "experimental" or for the use of medical devices that haven't been formally approved by the Food and Drug Administration...

Evaluation of Orphan Products by the U.S. Food and Drug Administration

1992 ◽  
Vol 8 (4) ◽  
pp. 647-657 ◽  
Author(s):  
Marlene E. Haffner ◽  
John V. Kelsey
Keyword(s):  
Drug Administration ◽  
Rare Diseases ◽  
Food And Drug Administration ◽  
Orphan Drugs ◽  
Marketing Approval ◽  
Drug Products ◽  
Governmental Agencies ◽  
Number Of Patients ◽  
Life Threatening ◽  
The U.S

AbstractOrphan drug products generally are used in treating or preventing rare diseases. The small number of patients available for study may create special problems in the evaluation of these products. This paper examines some of the special problems that are associated with the design and implementation of studies to evaluate the safety and efficacy of orphan drugs. The U.S. Food and Drug Administration (FDA) has not established special criteria for evaluating orphan drugs per se, but the FDA has been flexible in evaluating drug products that present special problems, especially when these products are for treatment of serious of life-threatening illnesses. The FDA and other U.S. governmental agencies also have taken steps to promote the development and availability of drugs for rare diseases, including making these products available to patients who are in need, even before the drugs have full FDA marketing approval.

scholarly journals KEWENANGAN BADAN PENGAWAS OBAT DAN MAKANAN TERHADAP PERDA PROVINSI BALI NO 5 TAHUN 2012 TENTANG PENGENDALIAN PEREDARAN MINUMAN BERALKOHOL

2013 ◽  
Vol 2 (3) ◽  
Author(s):  
I Putu Mahentoro
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Alcoholic Beverage ◽  
Provincial Government ◽  
Alcoholic Beverages ◽  
Ministry Of Health ◽  
The Public ◽  
The Republic ◽  
The Government ◽  
Imported Foods

ABSTRACTThe research was conducted based on the same authority which is ownedby the two institutions, namely Food and Drug Administration of the Republic ofIndonesia and Bali Provicial Government in monitoring and controlling ofalcoholic beverages in Bali.The results of this study demonstrate the Food and Drug Administrationand the Provincial Government of Bali have the same authority to supervise andcontrol alcoholic beverages in Bali. Bali Local Government Regulation Number 5of 2012 on the Circulation of Alcoholic Beverage Control only requires each hasa label on alcoholic beverages issued by the Government of Bali has to bedistributed to the public, while the authority of the Food and Drug Administrationis regulated in the Regulation of Minister of Health of the Republic of IndonesiaNumber 382/MENKES/PER/VI/1989 on Registration of Food that requires allfood produced both by local producers and imported foods are required to beregistered to the Ministry of Health through the Food and Drug Administration.In the Regulation Number 5 Year 2012 did not include the authority of theFood and Drug Administration (the Empty Norms) so that the Food and DrugAdministration can not perform optimally the law enforcement againstmanufacturers, distributors and sellers of alcoholic beverages in violation. Tocope with the condition it should be a amendment in the Bali ProvincialRegulation Number 5 of 2012 by stating firmly and clearly the authority of theFood and Drug Administration related to the registration of food, which requiresthat for all foods and beverages that will be distributed to the public must beregistered to the Ministry of Health through the Food and Drug Administration.

scholarly journals Is the Food and Drug Administration Safe and Effective?

2008 ◽  
Vol 22 (1) ◽  
pp. 85-102 ◽  
Author(s):  
Tomas J Philipson ◽  
Eric Sun
Keyword(s):  
Drug Administration ◽  
Drug Safety ◽  
Food And Drug Administration ◽  
Product Liability ◽  
The United States ◽  
Liability Law ◽  
Life Saving ◽  
Prescription Drug User ◽  
Before And After ◽  
Future Work

In the United States, the Food and Drug Administration (FDA) provides public oversight of the safety and efficacy of drugs; medical devices; biologics like vaccines and blood products; cosmetics; radiation-emitting electronic products; veterinary products; and all foods, except meat and poultry (which are regulated by the Department of Agriculture). According to the FDA, the products it regulates account for more than one-fifth of U.S. consumer spending. In the area of medical products, the FDA is responsible for determining whether marketed products are both safe and effective before and after they have been marketed. In this paper, we will explore whether the policies of the agency itself are safe and effective. We stress two issues, one static and one dynamic. The static issue concerns the potential duplication inefficiency when product safety is protected not only by the FDA but also by the private sector through product liability law. Put another way, what is the rationale for using product liability and the FDA to regulate drug safety? While intuitively it may seem that two systems must be better than one in ensuring drug safety, each system comes with costs. We then turn to the dynamic issue, the speed–safety trade off, and consider the extent to which higher safety is achieved at a cost of later market entry of effective and even life-saving products. We assess the Prescription Drug User Fee Acts (PDUFAs), which increased the speed of the agency's regulatory process starting in 1992, although according to some, at the cost of reducing drug safety. We conclude by suggesting a research agenda for future work on the Food and Drug Administration.

Why Regulate Medicines?

2016 ◽  
Author(s):  
Michael Kinch
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Scientific Understanding ◽  
Sulfa Drug ◽  
High Profile ◽  
Life Saving ◽  
Yellow Journalism

The prehistory of the modern pharmaceutical era is recounted, with emphasis upon the products, including the emergence of snake oil remedies, tapeworm diets and dangerous yet contemporary quack medicines such as Laetrile. As the magnitude of public outrage increased at the turn of the last century, the rise of yellow journalism highlighted spectacles that revealed further abuses and propelled high profile muckrakers to target adulterated products, including an emerging product known as Coca-Cola. As scientific understanding of infection grew, so did the potential for abuse, which culminated in a life-saving and revolutionary pre-antibiotic sulfa drug. However, the adulteratoin of this new breakthrough medicine resulted in the poisoning of more than 100 children in 1938. The disaster arose when a form of the drug was targeted at young by using a sweet elixir, which gained its taste by dissolving the medicine in radiator fluid. The resulting tragedy ushered in the era of the modern Food and Drug Administration (FDA).

INSIDE INDUSTRY

2015 ◽  
Vol 19 (06) ◽  
pp. 35-39
Keyword(s):  
Bladder Cancer ◽  
Drug Administration ◽  
Rare Diseases ◽  
Oncolytic Virus ◽  
Food And Drug Administration ◽  
Phase Iii ◽  
Cancer Drugs ◽  
Research Risks ◽  
Lost Decade

Two Promising Phase III Cancer Drugs: SIRT & Afatinib CAVATAK™ Presentations at Oncolytic Virus Therapeutics Conference Reinforce Potential in Bladder Cancer and Melanoma Receptos subjected to M&A Speculation Antibiotics Research Risks another Lost Decade while Rare Diseases Research Steams Ahead, Global Patent Study Reveals Intertek gains Official Accreditation with Philippines Food and Drug Administration

scholarly journals An introspection of quality of novel drug approvals by United States Food and Drug Administration

2018 ◽  
Vol 8 (1) ◽  
pp. 84
Author(s):  
Rekha Mehani ◽  
Ajay K. Shukla
Keyword(s):  
United States ◽  
Drug Administration ◽  
Rare Diseases ◽  
Food And Drug Administration ◽  
Medical Needs ◽  
Novel Drugs ◽  
United States Food ◽  
States Food ◽  
Drug Approvals ◽  
Novel Drug

Background: United States Food and Drug Administration (FDA) is the fastest drug review agency in the world. FDA is responsible for protection of the public health by assuring that foods are safe, wholesome, sanitary and properly labelled. Approved Novel drugs are often innovative products that serve unmet medical needs or otherwise help to advance patient care.Methods: FDA novel drug approvals were analysed from calendar year (CY) 2012 to 2016 on the basis of three criteria i.e., impact, access and predictability. Impact measured on the basis of: percentage of novel drug approvals (a) first in class (b) for rare diseases. Access measured on the basis of: percentage of novel drug approvals (a) first cycle approval (b) approval in the U.S. before other countries and (c) percentage of priority reviews. Predictability measured by: the percentage of novel drug approvals that met the PDUFA goal dates for the application review.Results: Total number of novel drugs approved from CY 2012 to 2016 was 176 (average 35 novel drugs/ year). Impact of novel drug approvals: 40% were first in class and 39% were for rare diseases. Access of novel drug approvals: 84% were first cycle approval, 60% were approval in US before other countries, 51% priority reviews among novel drug approvals. Predictability of novel drug approvals: 97% approvals able to meet PDUFA goal dates for application review.Conclusions: Novel drug approvals during CY 2012-2016 had a high quality which is very much evident by their high impact, good access and high predictability.

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