Navigation Links
Appraisal of FDA’s Drug Safety Proces

A team of experts criticized Food and Drug Administration (FDA) for not being able to effectively track the safety of new drugs and take action promptly for problems.//

The Institute of Medicine’s report probably will strengthen the discussion on the safety of the country’s drug supply and the competence of the FDA.’s supervision. A serious discussion began in September 2004 when Merck removed its popular arthritis drug, Vioxx, after long-term use was associated with an increased risk of heart attack and stroke.

At the request of the FDA, the Institute of Medicine, a nonprofit organization formed by Congress to advise the federal government on health issues, conducted the study. According to the Institute of Medicine more funds, people and power are required in FDA to ensure it upholds focus on the safety of the drugs it regulates throughout the time they are on the market. Cultural modifications are also required to prevent the tensions that can upset the evaluation of drugs' risks and benefits.

Labeling and advertising restrictions on newly approved drugs are also needed to emphasize the doubts that remain about their safety, according to the institute in "The Future of Drug Safety," a report issued Friday.

According to the institute, a catastrophe in drug safety seemed to have appeared.

"We found an imbalance in the regulatory attention and resources available before and after approval," said Sheila Burke, chairwoman of the committee that wrote the report. "Staff and resources devoted to pre-approval functions are substantially greater. Regulatory authority that is well-defined and robust before approval diminishes after a drug is introduced to the market."

"Nor does FDA have the resources to keep up once the drugs reach the market in assessing safety or informing the public about any risks that might develop.

"I am committed to taking additional steps and will look to the initiatives recommen ded by the Institute of Medicine, to ensure we continue to fulfill our mission," said Dr. Andrew von Eschenbach, the FDA's acting commissioner. Others within FDA were quick to hype the steps the agency's already taken.

"We're simply saying we have been on a trajectory to address the issues," said Dr. Janet Woodcock, the FDA's deputy commissioner for operations.

Burke called much of the effort little more than "moving boxes" around on organizational charts. "They have not been an integrative solution. They have addressed pieces of it but not in a fulsome way," she said.

The institute recommended a series of steps to enhance safety review, like improving FDA's budget whether through an appropriation from Congress or taxes. It also advised to lift restrictions on how FDA can spend the charge collected from drug companies. Those fees now finance the cost of reviewing new drugs before approval.

The institute recommended the FDA to appraise the safety of all new drugs five years after their introduction, making their initial approval more or less speculative and subject to withdrawal.

A logo, probably a black triangle will be present on drugs for 2 years warning patients and doctors that doubts may remain about their risks and benefits. Advertising would be limited in that period, if officially acceptable.

A drug industry group responded unperturbedly to that proposal. "Drugs are approved as safe and effective by FDA under the conditions that are prescribed on the label. The label can highlight that there are issues with the drugs, with respect to how they are used. I don't think it's fair to characterize all new drugs as requiring heightened regulatory uncertainty," said Alan Goldhammer of the Pharmaceutical Research and Manufacturers of America.

Some had expected the report to advise the introduction of a distinct center to supervise the safety of drugs, however, it did not. The report recommended t he Congress to give FDA the regulatory authority to make pharmaceutical companies to study the risk of their drugs once they are on the market.

"Vioxx was like a dead canary in a coal mine, a warning that worse may yet come. Today there's no question left that we need to strengthen post-market surveillance in order to improve drug safety and save lives," said Sen. Charles Grassley, R-Iowa, who with Sen. Christopher Dodd, D-Conn., has introduced legislation that would give the FDA such authority.

"This report confirms what many of us in Congress have been arguing all along - that the Food and Drug Administration's authority must be strengthened to empower the agency to take rapid and decisive actions on drug safety," said Rep. Rosa DeLauro, D-Conn. DeLauro is the ranking Democrat on the House subcommittee that oversees the FDA and its budget.
GT
'"/>




Related medicine news :

1. Tissue implant scandal heightens FDA’s concer
2. First Implantable artificial heart gets FDA’s approva
3. New standards for Human Research Safety
4. Safety of soy under suspicion
5. The Safety Of Prenatal Ultrasounds Questioned
6. Report on the Safety and Effectiveness of Melatonin supplements
7. Monitoring Drug Safety
8. Safety Of Indian Sex Workers At Risk Due To Poor Condom Usage
9. Safety Of Heart Drug Questioned
10. Race Was Used To Determine Safety Of Blood
11. Patient Safety Forces Closure Of Hospital
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library ... City Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ... for fumigation is not a common occurrence, but a necessary one in the event that ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and ... their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took ... the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive ...
(Date:6/24/2016)... ... , ... Marcy was in a crisis. Her son James, eight, was out of control. Prone ... physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If ... at my other children and say he was going to kill them. If we ...
(Date:6/24/2016)... ... ... of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair Minimum Wage’ ... 2020 and then adjusting it yearly to increase at the same rate as the median ... floor does not erode again, and make future increases more predictable. , The company is ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... the Frederick area economy by obtaining investment capital for emerging technology companies. ... years that have already resulted in more than a million dollars of capital ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Research and ... Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data derived ... Assessment of major trends with potential impact on the market ... of market segmentation which comprises of sub markets, regional and ...
(Date:6/23/2016)... 2016 Bracket , a leading clinical trial ... clinical outcomes platform, Bracket eCOA (SM) 6.0, at the ... – 30, 2016 in Philadelphia , Pennsylvania.  ... Assessment product of its kind to fully integrate with RTSM, ... eCOA 6.0 is a flexible platform for electronic clinical outcomes ...
(Date:6/23/2016)... and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of ... Farma Brasil as the company,s second affiliate in Latin America . ... ... Manager of Astellas Farma Colombia ... ...
Breaking Medicine Technology: