Navigation Links
Moratorium Proposed on Advertisements of Newly Approved Drugs

The battle between consumer interests and those of the pharmaceutical industry has got sharper in the US. On Wednesday a US Senate Committee approved// a bill that would clothe the Food and Drug Administration (FDA) with necessary powers to require drug makers to wait two years before advertising a newly approved drug directly to consumers.

The measure would give health officials new powers to fine companies that fail to do post-approval studies and to ban advertising of a new drug to consumers for two years. The safety of new medicines would be reviewed 18 months and three years after they reach the market.

In the last decade the ad spend of pharmaceutical firms has surged fivefold, it may be noted, to more than 5 billion dollars annually.

Promoting new prescriptions on TV entices consumers to demand those drugs from their doctors, potentially before individual physicians are familiar with the side effects and risks. That raises health and safety issues, lawmakers and consumer groups say.

The intent of the legislation is to give physicians more time to review the safety and effectiveness of new drugs before consumers have a chance to see advertisements.

The changes are a response to Merck & Co 's 2004 recall of painkiller Vioxx and complaints the Food and Drug Administration did not respond quickly to early signs of heart problems with the drug.

The legislation would codify FDA and industry plans to extend drug and medical device maker fees for the next five years to help speed reviews and partly fund safety checks.

"The bill establishes a new way to oversee drug safety that is flexible enough to be tailored to each new drug, yet strong enough to allow decisive action when problems are discovered," said Senator Edward Kennedy, a Massachusetts Democrat who chairs the Senate Health, Education, Labor and Pensions Committee.

The Bush administration objected to several provisions, saying br oad risk management strategies were not needed for every drug.

The bill is "overly onerous" and "could actually have the unintended effect of slowing down drug approvals -- while doing little to address the core issues of drug safety," Health and Human Services Secretary Mike Leavitt said in a letter to Kennedy.

The measure did not include creation of a path for FDA approval of generic biotech medicines, but Kennedy expected that would be added later.

The Senate committee also voted 11-9 to amend the bill to subject medical marijuana to FDA safety and effectiveness requirements.

The drug firms themselves charged their First Amendment rights were under attack. The First Amendment to the United States Constitution is a part of the United States Bill of Rights.

It prohibits the federal legislature from making laws that prohibit free exercise of religion or infringe on the freedom of speech or the freedom of the press and so on.

The new bill also would change incentives for pediatric research that have been lucrative for drug-makers. It would limit the extra patent time awarded for pediatric studies to three months for drugs with more than one billion dollars in annual sales. Other drugs could still receive six months.

The measure did not include creation of a path for FDA approval of generic biotech medicines, but Kennedy expected that would be added later.

The Senate committee also voted 11-9 to amend the bill to subject medical marijuana to FDA safety and effectiveness requirements.
GPL
'"/>




Related medicine news :

1. Addition Of Folic Acid In Flour Proposed To Arrest Birth Defects In The UK
2. Valentines Day Attraction: Sale Of Condoms In School Proposed
3. Uproar against the Government’s Proposed Quot
4. AIDS Sufferers Protest against Proposed Patent for Tenofovir
5. Medical Students Protest Proposed Tabling of Reservation Bill
6. Prime Minister Visits the Proposed Super Hospital Site
7. Registration Compulsory For Nursing Homes, Clinics – Says A New Proposed Law By Health Ministr
8. Proposed Compulsory Treatment For Alcohol Addicts
9. Six More Quality Health Care Canters Proposed by Indian Government
10. Misleading Advertisements for Prescription Drugs
11. Madras High Court Disapproves of Comparative Advertisements
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at ... of the most popular and least understood books in the Holy Scriptures, Revelation. The ... that have baffled scholars for centuries. Many have tossed it off as mere rubbish, ...
(Date:10/13/2017)... ... ... “America On The Brink”: the Christian history of the United States and ... of published author, William Nowers. Captain Nowers and his wife, Millie, have six ... years in the Navy. Following his career as a naval aviator and carrier ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... meet the demand of today’s consumer and regulatory authorities worldwide. From Children’s to ... and tested to meet the highest standard. , These products are also: ...
(Date:10/12/2017)... ... October 12, 2017 , ... Information about the technology: , ... to enable prevention of a major side effect of chemotherapy in children. Cisplatin ... patients. For cisplatin, hearing loss is FDA listed on-label as a dose limiting ...
(Date:10/12/2017)... ... 12, 2017 , ... On Saturday, October 21, the Health & Wellness Center ... to raise money for the American Heart Association Heart Walk. Teams of up to ... together to keep their treadmills moving for 5 hours. Treadmills will start at 7:00 ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... 2017 AVACEN Medical , Inc. (AVACEN) announced ... 2017 New Product Innovation Award for Its fibromyalgia pain ... secondary medical device market research by Frost & Sullivan,s industry ... drug-free pain relief product, the AVACEN 100, offers a safe ... widespread pain. ...
(Date:10/12/2017)... , Oct. 12, 2017 West ... in innovative solutions for injectable drug administration, today announced ... the market opens on Thursday, October 26, 2017, and ... results and business expectations at 9:00 a.m. Eastern Time. ... or 253-336-8738 (International). The conference ID is 94093362. ...
(Date:10/11/2017)... , Oct. 11, 2017  Caris Life Sciences ... on fulfilling the promise of precision medicine, today announced ... joined Caris, Precision Oncology Alliance™ (POA) as its 17 ... centers, the St. Jude Crosson Cancer Institute will help ... the use of tumor profiling, making cancer treatment more ...
Breaking Medicine Technology: