FDA User Fee Signed Into Law

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President Obama on Monday signed the Food and Drug Administration Safety and Innovation Act, which makes it easier for the FDA to approve and fast-track new drugs and medical devices to market, and bolsters the FDA’s oversight of safety issues. The bill, which Congress approved last month, reauthorizes user fees that the FDA collects from the drug and medical-device industries. The fees must be reauthorized every five years. The bill also expands the FDA’s role in creating guidance for mobile medical apps. The Medical Imaging & Technology Alliance (MITA) applauded the signing of the bill. “MITA and its industry partners worked closely with the FDA and Congress to develop a user fee agreement that improves the pre-market review process, while safeguarding patient access to safe and effective medical imaging and radiation therapy technologies,” said Gail Rodriguez, Executive Director of MITA, in a statement. The bill creates a new fee for companies that sell generic drugs, and it makes several changes to FDA policy to speed up the approval process of new products, in addition to the funding of a new approval pathway for biosimilar biologics, a class of drugs established by the Affordable Care Act. Congress sent the bipartisan-supported bill to Obama's desk in late June, just before the Supreme Court’s decision to uphold the Affordable Care Act. Any overlap with the ruling could have prevented the FDA bill from passing in its current form.