WASHINGTON — A Food and Drug Administration bill designed to increase inspections of foreign drug factories, while also speeding approvals of new drugs at home, is headed to the president’s desk after an overwhelming approval in the U.S. Senate.
The Senate approved the must-pass piece of the legislation by a vote of 92-4, and President Barack Obama is expected to sign it into law within days.
The core of the bill is critical to the FDA: It bolsters the agency’s budget with billions of dollars in drug industry fees for scientists who review new medicines. For the first time, generic drugmakers will pay review fees to speed the approval of their products. Branded drugmakers have paid those fees for 20 years.
Lawmakers seized on the legislation to address recent concerns about the safety and quality of prescription medicines, especially those that are imported. The bill also gives the FDA new tools to fight counterfeiting and drug shortages, which have made headlines in the past year.
“This legislation will help bring critical drugs and medical devices to market faster, protect patients from drug shortages and manufacturing problems, and enhance the availability of low-cost generic drugs,” said Sens. Tom Harkin, D-Iowa, and Mike Enzi, R-Wyoming, who guided the bill through the Senate.
Public health experts say the most significant changes for consumers involve how FDA inspectors oversee foreign drug manufacturing facilities.
For more than 70 years, the agency has focused its inspections on U.S. factories. But most companies have moved their operations overseas to take advantage of cheaper labor and materials. Between 2001 and 2008 the number of U.S. drugs made outside of the country doubled, according FDA figures.
The bill passed by Congress would drop a requirement that FDA inspect all U.S. drug factories every two years and let it focus on foreign facilities, which it now typically inspects every nine years. The new bill requires that FDA inspectors target the most problematic manufacturing sites, regardless of whether they’re in the U.S. or overseas.
“This legislation will, for the first time, enable the FDA to regularly inspect foreign drug manufacturing facilities, which supply 80 percent of the ingredients in our medications,” said Allan Coukell, director of the Pew Charitable Trusts’ medical programs
The risks of unchecked foreign drug manufacturing hit home in 2008, when hundreds of U.S. patients suffered allergic reactions — some fatal — to a blood thinner imported from China. An FDA investigation concluded the drug had been contaminated, to reduce costs, with an ingredient that mimics the blood thinner heparin.
The bill would raise the maximum prison sentence for drug counterfeiting to 20 years, or $4 million, from just three years or $10,000, under current law.
Despite months of negotiation, the bill does not include a national tracking system, which public health advocates say is critical to weeding out counterfeit pharmaceuticals from the U.S. supply chain. Lawmakers said they couldn’t bridge longtime disagreements between the FDA and drugmakers over the scope and cost of the system, which would track shipments using electronic codes.
The legislation’s underlying purpose is to renew, through 2017, a program under which drugmakers pay the FDA set fees for the review of new products. Since it first passed in 1992, the Prescription Drug User Fee Act has allowed the FDA to hire hundreds of additional scientists in return for meeting certain performance goals.
Under the new bill, the FDA would collect $6.4 billion in fees from companies over five years beginning in 2013. About $1.8 billion, or nearly 30 percent, would come from new fees, including the first to be paid by generic drugmakers.
Whereas most new drugs are reviewed in 10 months, the typical review for a generic drug takes over 30 months. The FDA has a backlog of more than 2,700 generic drug applications awaiting review, according to the Generic Pharmaceutical Association. The new fees will be used to hire more scientists to speed up clearance of generic drugs.
The legislation also renews a similar program covering medical devices.
Senators hailed the legislation as a rare example of cooperation between Republicans and Democrats, but the fee agreements at its heart had almost nothing to do with Congress.
Those arrangements were worked out during more than a year of closed-door negotiations between the FDA and industry groups. The portion of FDA’s drug review budget that’s underwritten by industry has steadily increased since 1992 and is now more than 60 percent.
Consumer advocates complain that the agency has become too dependent on the companies it regulates. They say they were shut out of the discussions.
The nonprofit Consumers Union lobbied Congress for a year over what it calls loopholes in FDA’s approval process for medical devices. Of particular concern to the consumer group was that the FDA routinely clears some medical implants that are similar to older devices — even if the older products were recalled for safety reasons.
“This was an opportunity to improve the oversight of devices, and Congress has missed that opportunity,” said Lisa McGiffert, who directs Consumers Union’s Safe Patient Project.
As with prior reauthorizations, companies succeeded in adding a number of measures designed to speed approvals of their therapies.
A measure supported by medical-device makers requires the FDA to provide a rationale for denying approval of medical implants within 30 days. Medical-device lobbyists complain that the FDA has become overly cautious when reviewing routine medical devices.
Drug manufacturers also won faster approval for drugs that appear to have breakthrough potential. The FDA would be able to accept smaller, shorter clinical studies when reviewing first-of-a-kind medicines for life-threatening diseases.