A Medical Device Daily

The Coalition for 21st Century Medicine (Washington) said Tuesday that it "strongly opposes" a citizen petition filed by Genentech (South San Francisco, California) earlier this month, which the organization said will restrict the ability of laboratories to offer diagnostic tests to physicians and patients.

The coalition said that the company's request "threatens innovation in laboratory tests, would harm patient care and rests on flawed scientific and legal premises."

Saying it "represents some of the world's most innovative diagnostic technology companies, clinical laboratories, researchers, physicians, venture capitalists, and patient advocacy groups," the coalition describes its mission as encouraging "the research, development, and commercialization of innovative diagnostic techniques."

It said that in contrast, the Genentech petition, by requesting that the FDA approve all laboratory tests, "would delay the introduction of many critically needed diagnostic tests, and prevent others from ever being available."

Further, the coalition's statement said that "although implied to be narrow, the petition is sweeping in scope. Genentech maintains that the FDA should regulate all laboratory developed tests (LDTs) for use in drug or biologic therapeutic decision making."

LDTs, the coalition said, "are developed precisely for the purpose of helping physicians make therapeutic decisions for their patients, including the decision of which drug to prescribe. The overwhelming majority of LDTs fall within the scope of the petition."

The coalition said Genentech's citizen petition "relies on several incorrect assumptions," and among its "fundamental errors" that FDA review and approval is needed for all LDTs used in therapeutic decision-making "to ensure that claims made for the tests are scientifically proven."

Genentech "wrongly asserts," it said, that FDA approval is a prerequisite for claims to be considered "scientifically proven. FDA approval is not needed for a LDT's performance to be demonstrated. There are many other methods of establishing a LDT's performance, such as the publication of reproducible research findings in peer-reviewed publications."

It added, "In seeking to require FDA approval of all LDTs used to make therapeutic decisions, Genentech relies on statements which it alleges are 'unsubstantiated' relating to LDTs affecting usage of its own products."

The coalition said there is a "vast difference between not knowing how much data support a particular claim, and whether the claim is actually unsubstantiated. A lack of information about some LDTs does not justify a revolutionary change in the regulatory regime for laboratories."

Imposing FDA regulation is not needed to redress false or misleading claims, according to the coalition. "The Federal Trade Commission has jurisdiction over that type of misconduct, as do the existing state agencies that regulate laboratories. Concerns about allegedly inaccurate statements can be readily – and efficiently – addressed within the existing regulatory framework."

It added that the Genentech petition "entirely ignores that a rigorous, well-established regulatory system already exists for LDTs. Laboratories and their tests need to meet the demanding requirements under the Clinical Laboratory Improvement Amendments (CLIA). They are also regulated by various states, as well as professional societies. Superimposing FDA approval of LDTs on top of the existing regulatory requirements would result in redundant – and even conflicting – regulation."

The coalition said that overturn of the existing regulatory regime for LDTs "would impose huge costs on laboratories. Even when a company possesses the data necessary to obtain FDA approval, companies still incur huge regulatory costs – and delays – in navigating the FDA approval process."

Financial stress causing health problems

The latest victim of the economic recession could be your health. According to an AARP (Washington) survey, one in five adults, 45 and older, are suffering health problems due to financial stress. The survey details the healthcare problems and challenges many Americans are facing because of the current economic downturn.

Key findings from the AARP survey, "Impact of Economy on Health Behaviors," include:

• 20% of people 45 and older reported health problems due to financial stress.

• Nearly one-fifth, 22%, have delayed seeing a doctor due to the expense.

• 16% have had to use retirement savings or other savings to pay for medical care.

• 21% have cut back on other expenses in order to afford medical care.

• One in six, 16%, are not confident they will be able to afford healthcare in the coming year.

The survey found that health problems due to financial stress is having a greater impact on individuals in the 45-54 and 55-64 than on those 65 and older (22% and 25% vs. 13%, respectively).

AARP says that over the last five years, health insurance premiums for families have increased by 65%, and that the average cost of health insurance for an American family now exceeds the yearly income of a minimum wage worker.

It cites figures from the Kaiser Family Foundation that indicate insurance premiums increasing 119% from 1999 to 2008, while workers' earnings have risen just 29%.