DCL/DCL Cures Lupus Pharma Firm's FDA Red Tape Ills

DCL Cures Lupus Pharma Firm's FDA Red Tape Ills

By Alison Diana, former editor with InformationWeek

Data Conversion Laboratory resolves structured product labeling for Prastera

In its quest to improve the lives of patients with lupus, Health Science Funding LLC developed a groundbreaking new treatment drug -- but bringing Prastera to market proved more challenging.

Clinical trials demonstrated the 11-employee firm's medication significantly eased painful lupus flares, had no side effects, and halved the risk of breast cancer in patients. The medication takes a new approach to managing systemic lupus erythematosus (SLE), according to Health Science Funding, which needed to bring its treatment to the Federal Drug Administration's mandatory structured product labeling (SPL) in order to quickly get Prastera to doctors and patients.

Yet nine months after hiring a consultant to guide Prastera through the FDA's complex process, the medication was only partially listed and remained unavailable to the more than 1.5 million Americans suffering from lupus. Lags in communication, misunderstanding about product packaging, and confusion over whether Prastera was a medication or a medical device added delay after delay, said Mark Pohl, president of Health Science Funding.

"It was a comedy of errors. It was one foul-up after another. If it wasn't so vital, if patients' lives weren't at stake, if so much money wasn't at risk, it would have been amusing," he said. "The consultant didn't even understand that we were selling a medication, not a device. They didn't seem to understand we had two bottles in one box. Every day the product is not launched costs us a lot of money and keeps lupus patients in a lot of pain."

Recognizing it needed a true partner that could navigate the FDA's SPL processes in weeks, not months, Health Science Funding discovered Data Conversion Laboratory (DCL) via a Google search for top providers of complex data conversion services. When a person, not a machine, answered Pohl’s holiday weekend phone call, he was encouraged – but Health Science Funding's previous experience with the consulting firm tempered his optimism.

"It's critical for pharmaceutical companies to get their approved new medications into the hands of doctors and patients as quickly as possible, and not get held up over labeling issues," said Mark Gross, DCL president and CEO. "As pharmaceutical companies develop new delivery mechanisms, it's vital for service providers and the FDA to keep up so patients benefit from medical advances."

Proof Is On the Label

Unlike the previous consultant – which passed Pohl's calls around to multiple individuals who each needed to learn about Health Science Funding and Prastera – the entire DCL team immersed itself in Prastera, its packaging, labeling, and the medication itself, said Pohl. Because Prastera uses two bottles of medication in each package, its format did not easily fit into the boilerplate forms the earlier consultant used, leading the FDA to frequently reject its SPL application, he said. DCL's custom approach was better suited to Prastera's more unusual packaging, Pohl added.

With FDA SPL, a standard used to exchange product information, new medication descriptions include a header and body. The header features data such as the type of product, author, and versioning; the body provides product information in structured text and data element formats, according to the FDA website. The highly structured documents must meet specific formatting criteria that go beyond mere XML tags but also must include validation rules and standardization across measurements, for example.

DCL guided Health Science Funding through the process, including forewarning the company about validation errors the FDA might find. Because the previous consultant sometimes listed Prastera as a single drug instead of a kit containing two medications, DCL had to revise the entry and revalidate earlier information.

"Getting it right means not only putting out the right XML tags, but putting the right information in the SPL files and making sure clients get their medications to market fast," said Howard Shatz, DCL project manager "This whole process -- from our first phone call to dealing with the overrides -- took maybe four or five weeks. When they got that email from the FDA, Pohl was very happy."

No doubt those with lupus also are happier these days. Doctors now can prescribe Prastera, giving patients a new option in their battle against this painful condition. And next time Health Science Funding is ready to bring a new medication to market, patients can be assured it will arrive much faster since the company will work with DCL on the FDA SPL process from Day One.

Alison Diana, InformationWeek

Alison Diana was a former Senior Editor at InformationWeek