Submitted by: Phil Riebel 06/15/2013
A Simi Valley pharmaceutical printing company is challenging language in a congressional bill that would eliminate paper drug inserts for health care professionals and cut into its business. Beyond the economic toll, Pharmaceutic Litho President Jason Laurence worries that separating drug labeling information from the product would put patients at risk because health care professionals do not always have access to the Internet.
MedCity News - June 12, 2013
A Simi Valley pharmaceutical printing company is challenging language in a congressional bill that would eliminate paper drug inserts for health care professionals and cut into its business.
Tacked onto a bipartisan House bill focused on protecting America's pharmaceutical distribution chain from counterfeits is a section that would limit the availability of printed prescription drug information for health care professionals.
That section is a problem for Simi Valley-based Pharmaceutic Litho & Label Co., which prints pharmaceutical inserts and drug labels and has about 110 long-term employees trained in the highly specialized printing of prescribing literature. Pharmaceutic Litho, which moved from Chatsworth to Simi Valley in 2010, is a 50-year-old private business that counts Thousand Oaks-based biotechnology company Amgen as a customer.
Beyond the economic toll, Pharmaceutic Litho President Jason Laurence worries that separating drug labeling information from the product would put patients at risk because health care professionals do not always have access to the Internet. He said printed literature decreases the risk of prescribing errors, poor patient compliance and adverse events during power outages and natural disasters, in remote regions and when armed forces medical personnel are deployed.
The inserts targeted by the bill are those distributed to health care professionals, not those going to patients, but Laurence said the bill sets up a "slippery slope."
"We just believe as an organization that they'll get the physicians to go paperless and then it will be that much easier to go to patients," he said.
Big pharmaceutical companies and generic drugmakers are pushing to digitize the inserts to save money, say opponents of the move.
Robert Brooks, executive director of the Pharmaceutical Printed Literature Association, said the leaflets are inexpensive and would only save pharmaceutical manufacturers pennies. His organization is making extensive efforts to raise awareness, however, in what he calls a David-and-Goliath battle.
"We're a very small organization compared to (big) pharma," he said.
Brooks has toured Pharmaceutic Litho's Simi Valley facility and estimates 50 to 80 such printing businesses in the country would be wiped out if the bill were enacted.
"It would be, 'Poof, you're gone,' " he said.
The ripple effect would be felt from ink companies to transportation companies and equipment manufacturers all the way down to the people who clean uniforms, Laurence said.
Opponents say it is premature to require paperless prescribing literature because Congress is funding a Government Accountability Office study into the issue that is due out this summer.
Legislators who have raised concerns include Rep. Henry A. Waxman, D-Beverly Hills. During a June 3 House session, he said the language allowing electronic inserts in lieu of paper wasn't brought to a House committee's attention when it was reviewing the bill and he urged review.
At the same session, Rep. David McKinley, R-W.Va., argued in support of the bill and said the pharmaceutical industry and Food and Drug Administration have for years been in talks about eliminating paper.
"This is not an efficient way to distribute critical information about prescription drugs," he said. "Eliminating this wad of paper would save the consumers millions of dollars in printing and shipping costs."
Rep. Michael Michaud, D-Maine, said eliminating paper would be problematic for rural states like his, where Internet access can often be intermittent at best. He also said it would jeopardize more than 1,000 jobs in Maine and he urged a no vote on the bill.
The House of Representatives passed the bill June 3. A similar bill pending in the Senate does not contain the requirement that drug inserts be paperless. If that bill passes, Brooks said, the measures will move into conference committee to discuss merging the two before voting to make the merged bill law.
The Generic Pharmaceutical Association issued a statement commending the bill's passage and its author, Rep. Bob Latta, R-Ohio, saying it supports electronic prescribing literature because it "increases patient safety by modernizing the information exchange between pharmacies and manufacturers."
Latta's office did not return messages seeking comment.
In Washington, D.C., on Tuesday, Laurence met with Latta.
"It was a good meeting," Laurence said afterward. "I think there were probably things he hadn't considered before, but it was kind of an informative thing. We made our case."
On Monday night, the Simi Valley City Council unanimously approved a resolution opposing efforts by Congress to eliminate the availability of professionally printed drug information for health care professionals.