FDA and drug manufacturers agree to increase user fees by six percent.
Food and Drug Administration regulators announced Thursday an agreement was reached between the FDA and drug manufacturers, like Eli Lilly and Company and Pfizer, Inc., that would increase the user-fee part of the drug authorization process by six percent.
The current drug authorization process was set to expire, and with the new deal, the process would be renewed for five years, or through the end of 2017. The money garnered from the user fees would go toward the government’s part in the approval of brand-name drugs.
The extra funds are expected to add $40.4 million to the user-fee revenue during the next fiscal year. In fiscal year 2013 total is expected to be $712.8 million. The expected funds were announced in an e-mail from FDA spokeswoman Karen Riley, who said the agency will also be required to meet with the drug manufacturers during the review process to ensure that standards are being met and time is taken into consideration. Ideally, the reviews should be carried out in a time period lasting anywhere from six months to 10 months. The drug manufacturing companies fund 60 percent of the cost of the review of the drug.
According to the draft of the agreement, which has to be approved by Congress before the current law expires on Sept. 30, 2012, the FDA agreed to meet with industry representatives 12 days before the review agency is convened to allow the drug companies to gather the data that will be needed for the review process.
The accord between the FDA and the brand-name drug manufacturers, “"should allow more timely access to safe and effective new medicines," said David Wheadon, who is the senior vice president for scientific and regulatory affairs at lobbying group the Pharmaceutical Research and Manufacturers of America, in a statement.
In an additional part of the agreement, third-party reviews were agreed upon, with the third-party reviewer coming in to determine whether or not the FDA was doing its share in meeting the goals of the drug review. The agreement also included support for an online tracking system that would enhance drug safety by assessing any risks the drug could pose after being introduced into the market. The requirements for risk strategies mandated by the FDA should also be standardized, the agreement said.
Talks regarding a user-fee have been going on since July 2010, and both Eli Lilly and Pfizer have participated in the planning for the fee renewal. Companies such as Johnson & Johnson, which produces medical supplies, are working on a separate agreement with the FDA regarding user fees. According to meeting minutes, the device industry rejected to proposal to more than double the current user-fee structure, taking it from $295 million now to $770 million in 2017.