Congress Shortens Cycle For FDA Approval Process
July 28, 2016 at 4:25 p.m.
Federal legislation passed Tuesday that reduces approval time for medicines and medical devices may eventually spur development in the orthopedic industry.
"I think in time it will improve the environment in which we develop and market our products," Dane Miller, president of Biomet, said Thursday.
Keeping in mind that "nothing in Washington happens overnight," Miller said the legislation is part of an apparent change in attitude at the Food and Drug Administration.
"The regulatory process had become an adversarial process instead of a collaborative process," he said. The new legislation is a step in the right direction for a more streamlined and quicker approval process of new medical products, he said.
The bill passed Tuesday by the House of Representatives, which was co-sponsored by Indiana Congressman Steve Buyer, shortens the time required by the FDA to approve pharmaceuticals and medical devices.
Buyer called the FDA's present procedures "archaic," and said, "It takes 12 years and costs $350 million for the average new medicine to go from research laboratory to the first American patient who needs it."
While he did not say how long it will take with the new legislation, he said it would help provide access to individuals who need new medications or medical devices that are "bogged down in the lengthy approval process."
Miller said he hoped it would "eventually lead to a more open and productive relationship, instead of an adversarial relationship, with the FDA and eventually will allow new technological developments to move faster." [[In-content Ad]]
Federal legislation passed Tuesday that reduces approval time for medicines and medical devices may eventually spur development in the orthopedic industry.
"I think in time it will improve the environment in which we develop and market our products," Dane Miller, president of Biomet, said Thursday.
Keeping in mind that "nothing in Washington happens overnight," Miller said the legislation is part of an apparent change in attitude at the Food and Drug Administration.
"The regulatory process had become an adversarial process instead of a collaborative process," he said. The new legislation is a step in the right direction for a more streamlined and quicker approval process of new medical products, he said.
The bill passed Tuesday by the House of Representatives, which was co-sponsored by Indiana Congressman Steve Buyer, shortens the time required by the FDA to approve pharmaceuticals and medical devices.
Buyer called the FDA's present procedures "archaic," and said, "It takes 12 years and costs $350 million for the average new medicine to go from research laboratory to the first American patient who needs it."
While he did not say how long it will take with the new legislation, he said it would help provide access to individuals who need new medications or medical devices that are "bogged down in the lengthy approval process."
Miller said he hoped it would "eventually lead to a more open and productive relationship, instead of an adversarial relationship, with the FDA and eventually will allow new technological developments to move faster." [[In-content Ad]]