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The FDA is planning on taking several steps to increase generic drug competition in order to lower prices, the head of the agency told House lawmakers May 25.
FDA Commissioner Scott Gottlieb said his agency will make the generic drug review process more efficient by having better and more frequent dialogue with generic drug developers. He also said the agency will publish a list of the drugs that are off patent but don’t have any generic competition, so that generic drugmakers have more information on what development programs to pursue. In addition, the Food and Drug Administration is looking into whether there are ways to intervene in situations where brand-name drugmakers use risk-mitigation plans to keep generic versions of their products off the market, Gottlieb said.
The commissioner also said the hiring freeze at the FDA imposed by the Trump administration is officially over. Gottlieb made his remarks at a hearing on the president’s budget request for the FDA held by the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. This marks the first time Gottlieb has testified before Congress as the head of the FDA.
“Simply put, too many patients are priced out of the medicines they need,” Gottlieb said. “While the FDA does not have a direct role in drug pricing, we can take steps to facilitate entry of lower-cost alternatives to the market, and increase competition.”
Gottlieb said the FDA is “evaluating ways to streamline the process FDA uses to determine whether to waive the requirement that a generic applicant and brand company share” a risk evaluation and mitigation strategy (REMS).
The FDA sometimes requires a REMS from a drugmaker to ensure the benefits of the product outweigh its risks. Brand and generic drugs are required to have a single, shared REMS if the REMS for the brand drug contains elements to assure safe use (ETASU). The ETASU are established to mitigate a specific and serious risk listed in the labeling of a drug.
Some brand companies delay negotiations on shared REMS with generic companies to keep their products off the market. But the FDA can waive the requirement for a shared REMS in certain circumstances.
“We’re asking can FDA waive this requirement more readily than we have in the past, in situations where sponsors cannot reach agreement after a reasonable period of time on the implementation of a shared [REMS] system?,” Gottlieb said.
Rep. Robert Aderholt (R-Ala.), chairman of the subcommittee, said he is concerned that the president’s budget request proposes increasing the amount of user fees the drug and device industries pay to the FDA. He said Congress is already considering legislation to reauthorize the user fees and the legislation is based on agreements between the FDA and industry that took two years to work out.
The FDA’s user fee programs expire Sept. 30, and Congress is in the process of approving legislation to reauthorize them. The president’s fiscal year 2018 budget request released May 23 would increase industry-paid user fees by $1.3 billion to pay for the full cost of the FDA’s review and approval of medical products. This would be a major change in policy because the medical product user fees currently cover an average of 60 percent of FDA’s premarket review costs, though that varies depending on the type of product, according to a budget document on savings and reforms.
“These reauthorizations need to be complete by July, or, as I understand it, FDA will begin the process of reducing their medical product review staff,” Aderholt said. “This is a long way of saying that the agency’s chances of offsetting budget authority with user fees faces a steep uphill battle.”
Rep. Rosa DeLauro (D-Conn.) said the proposal to increase user fees “quite frankly is not going to happen.”
Gottlieb didn’t comment on the user fee proposal at the hearing. However, in response to a question from DeLauro on the lack of resources in the budget for food safety, Gottlieb said “I wasn’t involved in the formation of the budget. I want to make sure the agency has the resources it needs to fulfill its mission.”
DeLauro also said she is concerned that the FDA is reducing medical product review times “at the cost of rigorous scientific evaluation” and “this can have life-threatening consequences.”
St. Jude Medical implantable defibrillators are being recalled because of battery failure and “these devices were approved without any clinical data under an expedited review pathway,” DeLauro said. Also, she said a deadly form of cancer has been linked to breast implants and there’s also an issue of lead tests that provide inaccurate results.
These products were approved through the FDA’s 510(k) pathway, DeLauro said. “Why do we continue to use a pathway that doesn’t ensure patient safety?” A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective—that is, substantially equivalent—to a legally marketed device.
Gottlieb said he doesn’t want to speed up review times, but rather the overall efficiency of the development process. He said he wants “to make sure we have the right guidance and right scientific tools in place” to ensure the FDA is learning all it can about the safety and benefit of new products during the review process.
Gottlieb also reiterated his commitment to combating the growing opioid abuse epidemic.
“We need to make sure patients are only getting exposed to opioids in appropriate clinical circumstances and for an appropriate duration of time,” Gottlieb said. “No more 30-day prescriptions for a tooth extraction.”
On May 23, Gottlieb announced the FDA is establishing an opioid steering committee to explore and develop tools the agency can use to combat the epidemic.
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More information on the hearing is at http://src.bna.com/peO.
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