Prescriptions: This Week's Health Industry News

Gatherings of insurance executives and public health doctors this week will be looking at possible changes to the health care overhaul from dramatically different perspectives.

America’s Health Insurance Plans, an industry trade group representing nearly 1,300 companies who insure more than 200 million Americans, holds its fall forum Monday through Wednesday in Chicago. The keynote address on Wednesday morning comes from Phil Bredesen, the Democratic governor of Tennessee and an outspoken opponent of parts of the legislation.

Governor Bredesen, who made his fortune years ago founding the insurance company HealthAmerica, has recently pressed his argument that the law would give insurers a powerful incentive to drop their company health-insurance policies for employees. In a conclusion challenged by supporters of the plan, he says companies would direct those workers to government-subsidized policies in the individual markets starting in 2014.

Norman J. Ornstein, resident scholar with the American Enterprise Institute, will talk about what the midterm elections mean for health care. Mr. Ornstein is an often liberal voice in a generally conservative think tank. He wrote in The Times last week that gridlock will be the theme of the new Congress and “confrontation will be the order of the day.”

The insurance group follows this with a two-day conference on preparing for state insurance exchanges — something that some governors are trying to stop.

The American Public Health Association is holding its annual meeting in Denver this week with the theme, “Social justice: a public health perspective.” This group, representing more than 12,000 doctors, nurses, administrators and other health workers, strongly supported the health care legislation.

In industry news this week, Pfizer will present data Wednesday at the American College of Rheumatology meeting in Atlanta on its experimental pill tasocitinib for rheumatoid arthritis. The company says its twice-daily pill, which could compete with more expensive injectable drugs, met two out of three primary endpoints in the first of six late-stage clinical trials. It improved symptoms and activity but not the remission rate.

The data was reported last week. “There’s no question it’s beneficial against arthritis,” Dr. Roy M. Fleischmann, principal investigator in the Pfizer-sponsored study and a clinical professor of internal medicine at the University of Texas Southwestern Medical Center, said in an interview Friday. “Then you think about the risks.”

The risks are primarily from higher cholesterol. Dr. Fleischmann said they are manageable. “It’s not perfect, but it’s got a really good benefit-risk ratio,” he said.

Other health-industry news may emerge from a symposium on obesity sponsored by the American Society of Bariatric Physicians Wednesday through Sunday. The meeting focuses on developing bariatric practices.

The group is led by Dr. Eric C. Westman of Duke University, coauthor of “The New Atkins for a New You,” who was recently interviewed about low-carb diets by my colleague Tara Parker-Pope.

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Prescriptions: House Panel Asks F.D.A. About Inspections in Puerto Rico

In a sign of what may be the new kind of post-election scrutiny of the Food and Drug Administration, leading members of the House Committee on Oversight and Government Reform sent a letter Monday to the agency asking whether understaffing at a district office led to oversight problems of drug manufacturing.

The letter, sent by Representative Edolphus Towns of New York, the committee’s current Democratic chairman, and Representative Darrell Issa of California, the ranking Republican, questions the actions of F.D.A. employees in Puerto Rico regarding their supervision of problems with drugs made at plants owned by the McNeil Consumer Healthcare unit of Johnson & Johnson and by GlaxoSmithKline.

The congressmen want the agency to provide by Nov. 17 a list of all manufacturing sites overseen by the F.D.A.’s Puerto Rico office, a list of all inspections conducted by agency inspectors in Puerto Rico over the last 10 years, and related documents.

In addition, the congressmen asked for an update on a recall of Motrin made by the Johnson & Johnson unit in Puerto Rico and F.D.A. actions surrounding that move.

A spokeswoman for the F.D.A. said the agency plans to respond to the inquiry after it receives the letter.

The House committee previously held two hearings related to manufacturing problems at McNeil plants, involving recalls of children’s Tylenol and other medicines.

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Prescriptions: F.D.A. Questions Drug Store Tests for Sexually Transmitted Diseases

8:41 p.m. | Updated with Rite Aid comment

A test to detect two common sexually transmitted diseases is now available in certain drug stores. But the Food and Drug Administration says it may have to come off the shelves.

The product, being sold at most Rite Aid stores, is the first test for chlamydia and gonorrhea to be sold through a drug store, according to Identigene, the test developer.

But the F.D.A. on Thursday sent a letter to Identigene saying the test had not been approved by the agency.

The action is the latest in a crackdown by the F.D.A. on medical tests being offered directly to consumers. In May, a similar F.D.A. letter led to the cancellation of a plan by Walgreens to sell a genetic test developed by Pathway Genomics that would predict a person’s risk of getting various diseases.

Steve Smith, executive director of Identigene, said the company has already replied to the F.D.A. saying that the test it uses in its laboratory, developed by Gen-Probe, has already been approved.

“There’s no reason for Rite Aid or anyone to discontinue selling the test,’’ he said Friday. Eric Harkreader, a spokesman for Rite Aid, said the company was investigating the matter.

But Dr. Alberto Gutierrez, director of in-vitro diagnostics for the F.D.A., said in an interview Friday that even Identigene’s urine sample collection kit needed to be approved.

Who will win this standoff is unclear, though the F.D.A. generally has the upper hand.

Regulation of diagnostics is clearly in flux. The F.D.A. is moving toward more oversight of so-called laboratory developed tests, which it once declined to regulate. These are tests offered by a single laboratory, with all samples sent to that lab, as opposed to a test kit that is widely sold to hospitals and laboratories. .

The agency is also moving to oversee tests, including genetic tests, offered directly to consumers over the Internet or through retailers.

New York State has its own strict regulation of tests, so the Identigene test is not being sold in Rite Aid stores in New York.

What Identigene is selling in Rite Aid is a urine collection kit, which costs $20. The consumer then must mail the urine sample, along with a $99 laboratory processing fee, to Identigene’s laboratory. The company says results will be available two to three days after it receives the sample.

Mr. Smith said an at-home test might encourage more people to be tested.

“We think there’s a significant proportion of this market who may prefer a private option,’’ he said. “There are many people who need to be tested but aren’t.’’

F.D.A. officials said they needed to first confirm the test was accurate.

There are “a lot of social implications if there is a false result, as you can imagine,’’ said Dr. Sally Hojvat, director of microbiology for the medical device division at the agency.

Another concern of the F.D.A. is whether people who test positive will have access to a doctor. Mr. Smith said Identigene has doctors on contract who will approve each test ordered and release the result. But he said the company could not ensure the doctors would talk to patients.

Cases of chlamydia and gonorrhea cases are supposed to be reported to the Centers for Disease Control and Prevention. It is not clear who would be responsible for that with the home test.

The C.D.C. estimates there are about 2 million new cases of either chlamydia or gonorrhea in the United States each year. Many of the cases produce no symptoms, meaning people can spread the diseases unknowingly.

Various diagnostic tests have been approved by the F.D.A. for sale over the counter in drug stores, including those for pregnancy, blood glucose, cholesterol and even H.I.V.

Identigene, which is based in Salt Lake City, is affiliated with an ancestry testing company called Sorenson Genomics. Three years ago, Sorenson and Rite Aid introduced what they said was the first DNA test to be sold through a drug store – a paternity test.

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