WASHINGTON — Nearly 90,000 Maryland jobs come from the state’s 400 biotechnology companies so when a senior Democrat on the Senate committee looking into industry regulations asks for a meeting, local businesses are the first to the table.
Sen. Barbara Mikulski, D-Md., met with representatives from several Frederick County biotechnology companies Tuesday at MedImmune, a Frederick-based pharmaceutical firm. The discussion, the third stop on Mikulski’s Maryland biotech listening tour, focused on the Prescription Drug User Fee Act and the Medical Device User Fee Act.
Both laws, which expire in October without congressional action, allow companies to pay an extra fee to the Food and Drug Administration in order to expedite the drug or medical device approval process. The FDA uses the additional revenue to expedite approvals and bring products to markets sooner than the standard 180-day waiting period.
“The legislation is consistent with the message from companies,” said Dr. Judy Britz, executive director of the Maryland Biotechnology Center. “All of the companies keep their doors open every day at a certain cost, and every day a product’s not approved it’s an additional cost.”
As a senior member of the Senate’s Health, Education, Labor and Pensions Committee, Mikulski is looking into legislation’s effects on businesses in the state.
“In Maryland, biotech means jobs, jobs, job,” Mikulski said. “I’m proud to support research and innovation jobs in Maryland’s biotech industry keeping our state competitive in the global economy.”
Beyond renewal of the fee legislation, representatives stressed the importance of a consistent accelerated approval timeline. While a fee to the FDA cuts down the six-month approval process, but companies don’t know whether that means two weeks or four months.
“A company works very hard to get its product development done within a certain period of time, and then they go into an unpredictable mid-zone,” Britz said. “In order for us to have a vibrant innovation economy, we need to predictably have products approved within a reasonable period of time.”
But Public Citizen, a national consumer advocacy group, has written to members of Congress opposing renewal of the laws.
“User fees have created an untenable conflict of interest in which the Food and Drug Administration is literally in hock to the industry it is supposed to be regulating,” the group’s letter said. “The result has been a decline in safety standards at the FDA, with a resultant record number of drug withdrawals for safety reasons.”
Mikulski’s office is working to find a middle ground where the FDA has enough time to properly evaluate a product but companies can still create medical devices and pharmaceutical drugs can get to people more quickly.
The issue is particularly important to Mikulski and her work with the Bipartisan Working Group on Drug Shortages, which aims to close the gap between drug manufacturing and FDA regulation that sometimes results in these shortages, according to sources familiar with her work.
The two user fee acts are on track for passage in mid-summer, according to a Senate aide and some industry officials.
“Pretty soon we will be entering into the next phase of a presidential election and attentions will be in other places,” Britz said.