Archive for the ‘Health’ Category

Johnson & Johnson Medical Device Rejected by FDA

01 Mar

Johnson & Johnson is at odds with the Food & Drug Administration over the government agency’s rejection of the company’s medical device which administers a propofol-containing drug. Sedasys, which must be administered by an anesthesiologist, is a medical device that uses a mild sedative during routine medical tests for patients.
After the FDA rejected Johnson & Johnson’s request for approval, the agency requested more data involving anesthesiologists in the control group. According to the Wall Street Journal, the FDA said that it asked Johnson & Johnson for the information before the trial began, something that Johnson & Johnson denies.
"We did everything that we were asked to do," says Mike Gustafson, who oversees the Sedasys program at J&J’s Ethicon Endo-Surgery unit.
The percentage of applications for new devices to be approved by the FDA without delay dropped to 56 percent in 2009 from 74 percent five years previous. Companies pulled 17 percent of applications for new versions of devices in 2009, which was up from nine percent five years earlier. According to AdvaMed, a trade group for the medical-device industry, this was sometimes due to the fact that the FDA sought more information.
"It’s never been as bad as this," says David Nexon, senior executive vice president at AdvaMed.

People in the business community have criticized the FDA for changing their requirements in the middle of the approval process. This is not disputed by the government agency, which says that it does so due to the evolution of scientific findings in the years of the approval process, which may bring to light new questions.

No Comments

Posted in Health


Half of Americans Have Preexisting Medical Conditions

02 Feb

There are many debates over our healthcare system and how to improve it. One them involves people with pre-existing medical conditions and whether or not it is okay for insurance companies to discriminate against people who have them. Now, news of how many people who have preexisting conditions sheds some light on how important this aspect of the healthcare debate really is.

Secretary of Health and Human Services Kathleen Sebelius just released a study that states that up to half of all Americans under the age of 65 have medical problems that could fall under the definition of preexisting conditions. In the report, depending on the definition of a preexisting condition, between 17 and 46 percent of Americans may have problems getting health insurance. That means as many as 129 million Americans are at risk of not qualifying for health insurance, or at least only being eligible for state high-risk pools which are special coverage for people denied insurance due to their medical history.

The researchers at the Health and Human Services Department used findings from an expansive federal survey of medical expenditures in 2008, the most recent available, to come to the conclusion of how many people faced problems of preexisting health issues.

The ailments that may put people at risk of not qualifying for health insurance include cancer and chronic illnesses, such as heart disease, asthma and high blood pressure.

There is push back to these findings, both from Republicans who say that it is partisan PR on behalf of the Democrats and from the Insurance industry itself.

Robert Zirkelbach, a spokesman for the health insurance lobbying group America’s Health Insurance Plans, says that even though his group supports the reform of the individual insurance market, "this report exaggerates the number of people who are impacted."

If the provision for protecting people with preexisting conditions remains intact, the 2010 Patient Protection and Affordable Care Act will forbid insurance companies to charge sick patients more or reject sick healthcare applicants.

No Comments

Posted in Health