O’Rourke also points out that the location restrictions, while understandable, may pose challenges for those who are not in major urban areas such as Boston. “If you’re practicing out in central or western Massachusetts, you might be 100 miles from the nearest hospital setting,” she points out. But the law is the law, as she observes, and “there are still ways that you can provide education—you just have to work within that structure.”
Industry, Police Thyself?
The Massachusetts code mirrors, to a large extent, the voluntary code established by the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA actually updated its code last year, and the changes took effect on January 1, 2009. Among them was the banning of gifts that are either “reminder items” (eg, the pens and preprinted notepads that everyone used to collect in the exhibit halls at conferences) or items that are of benefit to the prescriber. The updated PhRMA code is also more explicit about the situations in which provision of meals is appropriate and about the need for disclosure of any relationship between a pharmaceutical company and a health care provider if the latter is involved in the development of CME programs, clinical practice guidelines, or formulary decisions.
This industry-wide code is part of the reason that PhRMA opposed the Massachusetts legislation. “We’ve said consistently that it is the most draconian law in the country,” says Marjorie Powell, Senior Assistant General Counsel for PhRMA. “We think it’s not necessary—in part, because of the PhRMA code. We think it doesn’t do anything to improve patient care. It simply involves everybody in the health care system in much more recordkeeping and potential disputes over potential violations.”
All PhRMA member companies and some nonmember companies have agreed to comply with the organization’s code; the names of all the companies’ compliance officers are listed on the PhRMA Web site (www.phrma.org), making it easy, Powell says, for a clinician to report a potential violation to the appropriate party. She adds that this provides “a great deal of both peer pressure and public pressure” for company representatives to comply with the code of conduct.
There are those who would suggest that a voluntary code administered by a leading industry organization may not be effective enough; that’s why laws like the ones in Massachusetts and Vermont become necessary. While it is not an apples-to-apples comparison, no one has been very impressed with the financial industry’s efforts at policing itself.
Brody, who authored the book Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry, says the effectiveness of the more robust PhRMA code will be proven if marketing expenses decrease. “If they’re not doing all those things anymore—the lavish dinners, giving out pens and notepads and so on—shouldn’t there be a reduction in cost somewhere?” he asks. “Until I see some hard numbers, I’m going to be skeptical. I’m going to look for some evidence that it actually is working. And I can see why a state would say, ‘Well, the track record being what it is, maybe your voluntary code will work, but maybe it won’t. Just in case, we’re going to have this law on the books.’”
But Powell points out that pharmaceutical and medical device manufacturers, like all health care companies, are subject to the federal Anti-Kickback Statute. The FDA reviews all materials that are presented to prescribers and surveys health care providers to determine what types of information sales reps have provided about medications and devices. And the Centers for Medicare and Medicaid Services, the Department of Justice, and state attorneys general all have enforcement authority.
“Frankly, they have very strong enforcement authority,” Powell says, “and they bring actions if they think companies either have been failing to abide by the federal requirements or have been lax in their own enforcement…. It’s sort of a misunderstanding to say that the only thing that regulates the industry is this voluntary code.
And while other states—including Oregon, Texas, Connecticut, Colorado, Illinois, and Maryland—are considering legislation that would either ban gift-giving or require public disclosure of it, the real battleground on this issue may be the US Congress. The devil may end up being in the details, but all parties are watching to see what progress the Physician Payments Sunshine Act will make at the federal level.
“We have consistently said that we think transparency has a place in the health care system, but that if there is going to be that kind of transparency, national reporting—one uniform standard—makes much more sense than 55 different standards,” Powell says. “So we in fact supported last year’s [version of the bill] because it had a national uniformity provision. This year, [that] provision is much weaker; it allows states to have their own additional reporting requirements.”