Imagine a cop responding to your plea for help after your house has been ransacked. After a brief interview, he presents you with a bill for $50 payable before he begins an investigation. “This is outrageous!” you say. “Sir,” he explains, “this fee is well within the guidelines provided by CRUFMA or Crime Reduction User Fees and Modernization Act.” Of course, this scenario is silly. It could never happen.

But it does. Readers who don't work directly with OEMs can be excused for being unfamiliar with MDUFMA (ma-duf-ma), more lengthily known as the Medical Device User Fee and Modernization Act. It's similar to the hopefully imaginary CRUFMA. The medical version lets the FDA charge device makers fees to review records collected during clinical trials. The FDA uses these trials to grant or deny a manufacturer permission to sell their new medical equipment. The FDA collected $21.9 million worth of these fees in 2003. They were intended to provide additional resources to improve FDA performance. But most makes up for low Congressional funding in FY03 and FY04.

Medical Design first railed against the fees because they have been climbing quickly since the 2003 act went into effect. For instance, the user fee for a PMA (Premarket Approval for a device for which there is nothing similar) jumped from $154,000 in 2003 to $206,811 in 2004 and $239,237 in 2005. Estimates are it will rise to close to $350,000 in 2007, unless modifications are made.

Rising fees discourage small companies from submitting devices for approval. If you work for a component manufacturer, you might think this isn't your problem. You're wrong. If the company to which you sell material, components, or know-how decides not to pursue the business, your company also loses.

The fees were a hot topic at the recent Medical Device Manufacturer Association (MDMA) meeting. Chris Chavez, former president of MDMA and present CEO of Advanced Neuromodulation Systems, argues for predictable and reasonable fees. The organization has suggested capping fees at the inflation rate, or changing the definition of “small company” to allow greater fee relief to those that need it. Other solutions would put a user-fee tax on the sale of approved medical equipment. The tax-fee spreads the load without punishing small companies or rewarding large ones.

Acting FDA commissioner, Lester Crawford, could sort this out. He's an honest man in a tough job. At the MDMA meeting he defended the fees. He pointed out that most developed countries charge them. And there are no fees for humanitarian devices or for equipment that treats childhood ailments.

Crawford also pointed to several positive outcomes from the fees. For instance, he says they let the FDA improve its performance with more manpower. They've funded the hiring of specialists such as software engineers, and experts in robotics and nanotechnology. Consequently, the time needed to approve a PMA has dropped 16% from 260 days in to 2002 to 218 days in 2004. A two-tier fee system charges lower fees for small businesses and eliminates the fees for some companies for a first PMA.

He also recognizes that the best solutions come from working together, and that the FDA cannot reform itself. It needs the MDMA and others for guidance.

That's all well and good, but here's the rub: The Federal budget gobbles some $2.5 trillion for FY 2006, yet squeezes the medical industry for about $30 million annually to supplement the FDA's budget of about $1.5 billion in FY06.

The main objection to the fees is based on principle: The fees pay FDA to do what it already receives a budget to do. If the budget is insufficient, raise it. Or how about privatizing MDUFMA functions? Sound crazy? So did the privatization of air-traffic control, but Canada did it. And the private delivery of mail was once unthinkable. What do you think?