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Pharmaceutical Companies Court Virginia Lawmakers For Rule Changes

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Some are skeptical of the effects of lobbying money on Virginia laws governing drugs called "biologicals."
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Some are skeptical of the effects of lobbying money on Virginia laws governing drugs called "biologicals."

Gov. Bob McDonnell took part in a news conference last week welcoming representatives of the pharmaceutical industry to Virginia's capital, and singing the praises of clinical trials in the Commonwealth. That might seem like a noble thing, but it could also be part of a push to improve the industry's image as it protects future profits through new state laws.

Jeff Trewhitt is a spokesman for a group called PhRMA, which represents the interests of about 60 drug companies in this country. He was in Richmond, Charlottesville, Lynchburg and Norfolk last week to share a report showing how many clinical trials have gone on in the state over the past 13 years, the amount of money spent and jobs generated.

"The report in Virginia is 1 of 18," Trewhitt says. "This has been a major part of my life for the last 15 months. Have suitcase, will travel."

You have to wonder why his employer PhRMA put Trewhitt on the road and organized a news conference in Richmond. Would member companies save a bundle if reporters spread the word about clinical trials and patients lined up to take part? Trewhitt says research is expensive, but little of that money goes to recruiting patients, since study partners usually pick up the tab.

"When the bio-pharmaceutical companies link up with local research institutes like the University of Virginia, they recruit the patients themselves," Trewhitt says.

So maybe the industry is doing this because it really cares about people and wants to promote important advances in medicine. Possibly, says Dr. Howard Brody, but not likely. He trained at UVA and now heads the Institute for Medical Humanities at the University of Texas.

"The pharmaceutical industry is a very profitable industry in general, and profitable industries in general don't invest a lot of money in things that don't pay off in some way for them," Brody says.

A closer look at legislation being considered by the General Assembly presents one other possible explanation. Virginia could become the first state in the nation to lay down rules for a new generation of generic drugs, patterned after what are called biologicals: proteins, hormones, vaccines and other treatments made from living cells. Many of the original biotech breakthroughs have been protected by patents for years, and they're fairly expensive, but the Affordable Care Act says the federal government must spell out how competitors can produce generics.

Congress and the Food and Drug Administration are debating the details, but drug companies aren't wasting any time. They appear to be going state by state to promote rules that would make it harder, or in some cases impossible, for pharmacies to substitute "biosimilar biologicals." PhRMA says those rules are needed to protect patients, but three trade groups representing pharmacists disagree.

One other fact deserves a mention. In 2009, the pharmaceutical industry gave nearly $810,000 to Virginia candidates. Among them was Gov. McDonnell, who collected $25,000. At last week's news conference, he was clearly pleased to see the people he called "my friends from PhRMA."

"I've really come to salute the industry," McDonnell said. "Our pharmaceutical companies do amazingly good work to be able to improve the quality of life and be able to create a significant number of jobs here in Virginia."

Which brings us back to Dr. Howard Brody. If ever an industry wants to influence lawmakers, he says, that four-letter word is magic.

"When you try to get your local state legislators to vote in your favor, you tell them, 'We're creating jobs in your region,'" Brody says.

Measures sponsored by Republican Del. John O'Bannon and Republican Senator Steve Newman were approved and await the governor's signature.

At least eleven other states are considering similar legislation to restrict substitution of cheaper biological approved by the FDA.

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