On August 18, 2017, President Trump signed the H.R. 2430 Food and Drug Administration Reauthorization Act (FDARA) into law. The FDARA will bring innovative new medicines into the manufacturing sector with added incentives to keep the biopharmaceutical industry in the United States.
More than 6 million Americans are employed in the biopharmaceutical and medical device industries in the United States. The United States is a leader in medical innovation. Keeping these jobs in the United States strengthens our economy. The FDARA is expected to expedite the implementation of medical advances to get new medications and medical supplies to patients faster without compromising patient safety. The FDARA will increase competition in the pharmaceutical market.
The H.R. 2430 Food and Drug Administration’s medical product user’s fees support small businesses, which improve the quality of our lives. They manufacture life-saving medicine, artificial limbs, and robotics. Medical laboratories and medical imaging technicians record, exchange, and transmit patient test results, genetics, and diagnoses. They amplify the progression of illnesses within worldwide databases to predict the best possible treatment options for each patient.
With the 21st Century Cures Act, the FDARA advances the digitization of the health innovation action plan. On Monday, August 14, 2017, the FDA revealed their action plan to implement the 21st Century Cures Act. The FDARA has four parts:
- Generic Drug User Fee Amendments
- Biosimilar User Fee Act
- Prescription Drug User Fee Act
- Medical Device User Fee Amendments
- Generic Drug User Fee Amendments (GDUFA)
The FDARA reauthorized the GDUFA to advance the FDA’s process of timely review of new drug applications. The GDUFA allows pre-submission of abbreviated drug applications for generics of already existing drugs.
Biosimilar User Fee Act (BUFA)
The BUFA, reauthorized for five years, allows the FDA to assess products which are biologically similar to biological products already in production. Biosimilar products are produced by competitors after the expiration of the original product’s patent.
Prescription Drug User Fee Act (PDUFA)
The PDUFA enacted in 1992 authorized the Food and Drug Administration to accept payments from pharmaceutical companies to pay for the protracted new drug approval process. The fees range from $1,019,050 to $2,038,100 with or without clinical trials. Additional approvals are $1,019,050. Product fees are $97,750.
Medical Device User Fee Amendments (MDUFA)
Medical device user fee amendments require medical device manufacturers to pay to register their names, offices, and subsidiaries with the FDA and to list medical devices with the FDA whenever they submit an application to market a new or modify an existing medical device in the United States. Partially approved forms and fees for swifter processing reduces the time required to introduce new medical devices in the United States. All individual medical device fees are under $250,000.
First Quarter 2018
The FDA intends to announce a voluntary pre-certification system for digital health product developers. Pre-certified developers can market health care software after a less detailed agency review. Detailed guidelines will establish when changes to medical software will require a new submission for approval by the FDA.
Also in the first quarter of 2018, the FDA plans to reveal its plan to regulate clinical decision support software. The FDA will also announce guidelines for the regulation of multifunctional wearable products which contain sensors and assess medical statistics and conditions.
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