WASHINGTON – American companies that make medical devices would face fewer restrictions and have a better chance of competing against foreign competitors under a section of a bill passed Wednesday by the U.S. House of Representatives.
Inside the Food and Drug Administration Act, which the House approved 391-2, is a section designed to bring about faster approval of new medical devices.
If the Senate goes along with the provision sponsored by Rep. Cathy McMorris Rodgers, the FDA will enter into agreements with other countries to streamline the regulatory requirements for premarket review, inspections and common international labeling symbols.
McMorris Rodgers said the amendment would help expedite approval of treatments and create jobs.
The medical equipment industry employs more than 8,700 people in Eastern Washington and more than 400,000 in the United States. But jobs are being threatened by the current FDA approval process, McMorris Rodgers said, putting U.S. companies at a severe disadvantage with foreign competitors.
“We need to unleash the power of American free enterprise to revitalize our job base, especially in high-paying industries such as medical technology where America has traditionally been the world leader,” she said. Patients who need the new devices and drugs will also benefit, she added.
Medical device manufacturers still face a 2.3 percent tax scheduled to take effect at the beginning of next year. But McMorris Rodgers said she will support repealing that tax when it comes up next month.
The FDA Act also extends the fees that drug and equipment manufacturers pay to help speed the approval process. The fees are set to expire in September but would continue another five years.