Why are they all so happy?

The new FDA Reform bill was passed last week after what we're told was a long battle among politicians and intense lobbying of pharmaceutical and consumer groups. It is the largest expansion of government regulatory powers over drugs in a decade. The bill’s primary author in the House, John D. Dingell, said it “strikes the proper balance between new drug-safety measures and ensuring consumers have access to innovative prescription pharmaceuticals in a timely manner.” And the Senate Health, Education, Labor and Pensions Committee Chair, Edward Kennedy, said: “This ought to be reassuring for every family about the safety of their prescription drugs.”

News reports have made it appear consumer protection has been improved and drug safety information has been made more accessible, but the provision that will have the most significant and longest lasting impact on the rights of consumers and the practice of medicine has received hardly a whisper.

Rather than go through an intense review of the 422-page bill, here are just a few parts of this legislation that might give us some cause to pause and think.

“Tightens drug advertising regulation?”

Despite the reassuring spin we hear in mainstream news, whether this legislation has actually tightened drug advertising regulation is open to debate. Some attention has been given to the fact that the toughest restrictions in the early drafts of the bill would have given the FDA authority to prohibit direct-to-consumer advertising of new drugs with serious safety concerns. Originally, both House and Senate drafts had also proposed allowing the FDA to block ads for new drugs in the first two or three years until their post-market safety information was better known, and later proposed that all ads for new drugs carry a special logo warning that not all side effects may have been found. There had also been proposals to require drug makers to devote more ad space to warnings and strike a better balance between positive and negative messages.

None of those made it into the final bill.

“Drug advertising hasn’t changed significantly,” Dan Jaffe, executive vice president of the trade group Association of National Advertisers told the Wall Street Journal. This was “a success for the entire advertising community,” he said. The advertising industry had lobbied hard because any ability to block drug ads would be “a business disaster.” Lobbyist for the advertising and media groups, Jim Davidson, told Advertising Age that “it was an earned victory attributable to very hard work on the part of a broad coalition.” In the U.S., pharmaceuticals were the tenth biggest advertiser in 2006, spending $5.3 billion, according to the paper.

Instead, the compromise reached will give the FDA power to review ads and impose fines on a drug company if its ads are found false and misleading — fines amounting to $250,000 for the first violation in any three-year period and not to go above $500,000 for any subsequent violation in a three-year period. With sales of prescription drugs in the United States last year of $274 billion, it’s easy to do the math and see who won that one and how much of a deterrent that will be in reality.

“Reduce conflicts of interest in the drug review process?”

Initial proposals set limits on the number of FDA advisory panel members who could have financial conflicts of interest with companies whose products are under review.

That provision was omitted. Instead, using 2007 as a baseline, they would only need reduce by 25 percent the number of allowable of conflicts of interest among the FDA reviewers.

“Protect American consumers?”

Other measures that found their way onto the cutting room floor, according to Congressional Quarterly, was language that would allow importation of less expensive drugs from several countries, a bill allowing the government to negotiate lower prescription drug prices, and amendments to the risk evaluation and mitigation strategies process which would have required drugs to have risk plans and regularly report adverse events, and an amendment requiring independent, outside review if information suggested a drug increased the risk of adverse events.

Money well spent?

The cornerstone of the package is a reauthorization of the FDA’s drug-approval program, funded by drug and device company user fees that finance FDA reviews of applications to speed bringing new drugs to market. Under the compromise, drug companies would pay a new user fee totalling some $225 million over five years that would fund FDA drug-safety activities.

As the Kaiser Daily Health Policy Report reported, the Pharmaceutical Research and Manufacturers of America said the measure is a “critical step to make our nation’s drug safety system — which already is the best in the world — even better.” And it reported the senior lobbyist for Pfizer as saying: “We’re really happy with [the legislation],” adding that it should “restore confidence in FDA’s oversight of drug safety.”

Lobbying appears to work. According to filings with the Senate Office of Public Records, lobbying by health interests surpassed $227 million in the first half of this year, the largest ever in history. As the Congressional Quarterly reported last week, the biggest spenders were Pharmaceutical Research & Manufacturers of America ($10.7 million), American Medical Association ($10.3 million), Amgen USA Inc. ($9.1 million), American Hospital Association, and Pfizer Inc.

The money shot — Safety monitoring at the expense of privacy and freedom?

The biggest, most crucial component of this bill has received little notice. Los Angeles Times staff writer, Ricardo Alonso-Zaldivar, was one of the few to call attention to it. Among the measures to allow the government to monitor drug usage in order to detect safety problems is the creation of a new government computerized system to scan our pharmacy and insurance records. As Alonso-Zaldivar reports:

The legislation calls for a database of 25 million patients by 2010, growing to 100 million by 2012.

For example, such a database could be used to compare patients taking a new painkiller with patients taking an older one. If the patients on the new drug start showing up in emergency rooms with heart attack symptoms in disproportionate numbers, that could be an indication that the drug is to blame. But there might other explanations. Perhaps the new drug is being prescribed to older, sicker patients. Or maybe it's being prescribed for unapproved uses. That's where the legislation would give the FDA new legal authority to require drug makers to conduct follow-up studies...

Information on drugs and the safety risks database for consumers and doctors would also be administered by the National Institutes of Health, according to Congressional Quarterly.

A governmental electronic database monitoring our drug usage to look out for our safety might sound good, until you put it together with a few other recent news stories. Just months ago, we learned that under a new proposal, a new federal agency would be empowered to determine how our private healthcare information is used and disclosed, and would “nationalize ownership and control of private patient data,” according to Twila Brase, RN, PHN, president of Citizens’ Council on Health Care. And we recently heard that, according to Julie Gerberding, director at the Centers for Disease Control and Prevention, the government is working to create a national healthcare system. Her first step was to call for government-run education for all doctors, nurses, pharmacists and other healthcare professionals.

There’s that snarly conflict when those who control our medical records are also in control over access and costs of prescription medications, the health information we get, and the medical care we receive. It’s a lot like the slippery slope debate over whether the government should have control over our genetic and other health information. Is it really about looking out for our safety and the common good, or “just one more means of rendering [us] helpless and vulnerable to the whims of bureaucrats who have their own interests in mind, not ours?” The government will have increased power, but have we been given any more power over it?

© 2007 Sandy Szwarc