By Kim Bae Kim and Mark D. LipskyJune 23, 2017 12:09:38While many companies have already responded to the FDA’s latest proposal, the C&D Association has decided to do something a bit more proactive.
Its recently posted a list of its demands for the FDA to implement its recommendations.
Among its concerns are the elimination of all generic and branded drug options, a requirement that the FDA make its own drug testing requirements, and a requirement for companies to disclose all drug costs.
The proposed changes were made to the proposed 2015 Food &drug Administration Modernization Act, which will expire in 2020.
For its part, the Canadian Association of Food &publishing (CAFE) says it supports the proposed changes, but is concerned about the FDA making changes that will negatively impact small business.
The group says that while it supports transparency and drug pricing, the FDA should also “follow its own research” and “propose appropriate data and privacy requirements” to ensure a free and fair competition for the industry.
“The CAFE believes the FDA needs to continue to review its existing drug pricing policies and establish data privacy requirements to ensure competition is not undermined,” CAFE President, Mike O’Connor, told TechCrunch.
“We believe the FDA is taking an important step in addressing the industry’s growing need for competitive access to generic drugs.
However, CAFE has concerns that the proposed reforms may lead to more restrictive drug pricing.”
The FDA’s proposed reform of the drug pricing rules is a step in the right direction, said CAFE Vice President of Regulatory Policy, Scott Hodge, who also happens to be a senior vice president for public policy at the Canadian Hospital Association.
“In our view, the proposed FDA reform would create incentives for drugmakers to provide greater competition in the marketplace,” Hodge told TechCulture.
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While the proposed reform could bring more competition to the market, the industry would need to take this step alone to address the need for meaningful competition.”
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