Disco was king the last time regulations were finalized for the most common drugs Americans use, such as cough medicine and aspirin.
So, Congress is taking a hard look at overhauling the rules for over-the-counter drugs. Lawmakers want to create a user fee program that gives the Food and Drug Administration more money to quickly revamp the regulatory program that oversees more than 300,000 over-the-counter products.
“While bell-bottom pants, I see, are coming back, we need to innovate in this sector,” said Rep. Greg Walden, R-Ore., chairman of the House Energy and Commerce Committee, which held a hearing on OTC drugs Wednesday.
An over-the-counter drug is approved one of two ways.
The first is the same way the FDA approves brand name and generic drugs. A drugmaker files an application with the FDA, which reviews it and then approves it before the drug hits the shelves.
The second, and by far more common way, is through a monograph system. That system lays out the rules and requirements for making and marketing a safe and effective drug.
Different monographs exist for different types of products. For instance, a monograph for cough medicine outlines the active ingredient that must be used in the formula.
A product that uses the monograph system doesn’t have to be reviewed by the FDA before it goes to stores. That helps new OTC drugs get approved much faster, especially if they have an active ingredient of a product that is already on the market, such as cough syrup.
However, the monograph system is more than 40 years old, and FDA officials say it hasn’t kept up with technological developments in drug production. And the agency has been bogged down trying to update monographs. The FDA started to evaluate the “monographs for 26 categories in 1972 and hasn’t finalized the monographs for each of them,” said Janet Woodcock, director of the Center for Drug Evaluation and Research, in prepared remarks before the House Energy and Commerce Committee.
“Approximately one-third of the monographs are not yet final, and several hundred individual ingredients (monographs can include multiple ingredients) do not have a final determination of safety and effectiveness,” Woodcock said in her remarks.
She added that a “number of planned safety labeling changes for monograph ingredients have not yet taken place while similar changes have already been made to prescription drugs containing the same ingredient.”
A major problem is funding and staffing. The FDA has 34 employees to review thousands of OTC drugs, compared with 18 people who review an application for a single new drug.
To improve the monograph system, the FDA and Congress are eyeing an approach that helped them with prescription drugs and devices: charging user fees.
The agency already has a user fee program in which brand name and generic drug makers and device manufacturers pay the FDA a fee for every new application. The agency uses that money to speed up the approval process through methods such as hiring new staff.
User fees traditionally receive bipartisan support. Last month, Congress and President Trump reauthorized the drug and device user fee programs for another five years.
Woodcock said that the current over-the-counter review system is far too slow. Challenges include limited resources to carry out reviews efficiently, which results in problems when responding to safety issues.
The over-the-counter industry says it is open to a user fee program, provided that it is modest.
“We believe the fee agreement strikes the right balance and will help achieve a more nimble regulatory structure for monograph drugs that would be a win-win-win for consumers, manufacturers and regulators,” said Scott Melville, president and CEO of the trade group Consumer Health Products Association, in prepared remarks at the House hearing last week.
Sponsors of the bill, called the Over-the Counter Monograph Safety Innovation and Reform Act of 2017, have released a draft on setting up the user fee program.
Reps. Brett Guthrie, R-Ky., Debbie Dingell, D-Mich., Bob Latta, R-Ohio, Michael Burgess, R-Texas, Diana Degette, D-Colo., and Gene Green, D-Texas, are co-sponsoring the bill.
