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:5/26/2016)... ... 26, 2016 , ... Intalere, the healthcare industry leader in ... inaugural Member Conference at the Paris Hotel in Las Vegas, Nev., May 17-20, ... America’s healthcare providers. , The conference was highlighted by the announcement of the ...
(Date:5/26/2016)... ... 26, 2016 , ... The Woodlands at John Knox Village , Florida’s ... care for living and healing, celebrated its grand opening, today. The Woodlands at John ... provided by Empowered Staff. , “This is an incredibly fulfilling time for John Knox ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... development solutions for drugs, biologics, consumer health and global clinical supply services, today ... Korea to support the company’s continued investment and strategic growth plans in the ...
(Date:5/26/2016)... ... May 26, 2016 , ... Memorial Day Weekend marks the unofficial ... is sharing tips to make sure your family and vehicle are ready to ... Council, there may be 439 deaths and an additional 50,500 serious injuries from motor ...
(Date:5/26/2016)... ... 26, 2016 , ... North Cypress Medical Center hosted its 9th ... Cypress. With the help of community partners, the event organizers raised $45,000 for the ... wounded service members and their families through health, wellness, and therapeutic support. , ...
Breaking Medicine News(10 mins):
(Date:5/26/2016)... 2016 TARE (Transarterial Radio-embolization) ... Savings and Overall Decreased Use of Hospital ... international specialist healthcare company, has today announced the ... Meeting of ISPOR (International Society for Pharmacoeconomics and ... (HCC) using yttrium-90 glass microspheres is associated with ...
(Date:5/26/2016)... WELLESLEY, Massachusetts , May 26, 2016 ... sequencing (NGS) has matured into an essential life science ... research and development applications. BCC Research reveals in its ... of a second growth phase, one powered by a ... applied fields.      (Logo: http://photos.prnewswire.com/prnh/20140723/694805 ...
(Date:5/25/2016)... 25, 2016 According to a ... (3D, 2D, 4D), by Therapeutic Area (Oncology, Cosmeceutical/Plastic Surgery), ... (Medical Device Manufacturers, Hospitals/ Clinics) - Forecast to 2021", ... Animation Market for the forecast period of 2016 to ... Million by 2021 from USD 117.3 Million in 2016, ...
Breaking Medicine Technology: