Industry laments FDA registration

Tuesday, January 26, 2010

WASHINGTON - The Food and Drug Administration's (FDA) redesigned  registration process for certain oxygen providers has been a nightmare, say industry stakeholders.

The FDA requires manufacturers of drugs and medical gases--including providers who fill cylinders--to register with the agency each year. On June 1, 2009, the FDA began accepting only electronic submissions. The problem: The registration instructions are difficult to follow and better suited to traditional drug manufacturers, say stakeholders.

"It's sort of like putting a square peg in a round hole," said John Willenbrock, president of Jamestown, N.C.-based Gas Regs, a consulting firm. "They are trying to make medical gases fit into the same mold as Lipitor. There's a lot of differences between how medical gases and traditional pharmaceuticals are manufactured."

Exacerbating the problem: An electronic system that is anything but user-friendly, he said.

"There's a lot of technical stuff you need to do, beyond general computer knowledge," said Willenbrock. "You have to jump over many hurdles."

Other problems include out-of-date software. When the new system launched in June, it would only work with Internet Explorer 6, for example. Many providers using Windows-based software were already using Explorer 8.

It all adds up to a process that is far more time-consuming then it should be, said Willenbrock.

"Firms that I've worked with have spent 40 hours or more in the process over the course of three or four months to get registered," he said.

Provider Lou Kaufmann completed the registration process in November--he started in August.

"We ended up taking a computer and getting rid of newer software and going back to old versions of things," said Kaufmann, vice president, patient/client services for Bethesda, Md.-based Roberts Home Medical. "It wasn't difficult once you could get the door open, but getting the door open was difficult."

Willenbrock and AAHomecare have met with the FDA to try and make the process more palatable for the HME industry.

"The next step is to try and get them to develop instructions uniquely for medical gases," said Willenbrock. hme