FDAAA Spelled Out at DIA - Pharmaceutical Executive

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FDAAA Spelled Out at DIA


PharmExec Direct

On Tuesday, during the Drug Information Association's annual meeting, a panel of leaders involved with the inner workings of FDA's Amendment Act (FDAAA) and its drug safety program explained the current state of the program and the challenges to implementing its numerous components.

The first order of business was explaining the current status of the Prescription Drug User Fee Act (PDUFA). Sandra Kweder, deputy director of FDA's Office of New Drugs, told the audience that PDUFA is now embedded within FDAAA.

"PDUFA got swallowed up like Jonah," Kweder said. "The intention of PDUFA 4 was to better balance work and staffing, and increase good review management principles as well as development of guidance. However, FDAAA now includes PDUFA, and the task requirements of FDAAA are mind boggling compared to PDUFA."

To the packed room of industry execs, Kweder described FDAAA as a big ship trying to turn very slowly. "Regulation has to be driven by science and society," she said. "However, science is difficult and changes constantly, and change is very hard. We use legislation only when big changes are needed."

She admitted that FDA has a lot of the same questions that industry does. "The legislation is extraordinarily complicated, and each question must be answered on a case-by-case basis. Every action letter we write has to undergo multi-party review to make sure we have it right. We have to justify every path taken and the documentation is profound."

The panel then went through the different parts of the amendment act and briefly explained the status of each section.

Risk Evaluation and Mitigation Strategies (REMS): As part of the FDAAA, FDA can now hold pharma companies accountable for how they distribute drugs, whether they conduct post-approval studies, and how they track adverse reactions. Pharma companies have always been able to submit their REMS plans for FDA review, but that is now a requirement, with penalties neglect. The panel also said that it is still working on a plan to handle all the REMS submissions.

"If a company came in with a solid REMS plan, FDA wouldn't have a way to hold pharma's feet to the fire and make them do it," said one panelist.

"Is there a template for risk management?" asked one audience member. "No there is no template," said Kweder. "With respect to REMS, our concern during the legislative process was that we urged congress not to confuse things by creating new ways of doing things," said Alan Goldhammer of PhRMA. "They took the opposite approach. We would like things to be harmonized internationally. We would like a common way of doing things."

"Harmonizing risk management sounds nice, but I don't know what it means to harmonize risk management," Kweder said. "One of the things we have to take into account is that some aspects of REMS have to do with how medical care is delivered. We see differences between the US and Europe, and we have to take those things into account."

Pediatric studies: This component is on track. Pediatric study results now go in all labeling, and the panel said that usage of this key public health tool is underway. The challenge is in handling the volume of committee review items, as tracking burdens are unprecedented.

Labeling requirements: Under the new rules, FDA can order pharma companies to list all new safety recommendations on drug labels. This is especially helpful in class labeling, as it will decrease the back-and-forth with individual firms, a process that delays labeling.

Postmarketing studies: With FDAAA, the feds can ask pharma companies to conduct further clinical studies after a drug is on the market. "We are still learning what is required versus agreed," said Kwede. "We have to think hard about what is essential. FDA reviewers are not out there doing studies. They don't know what a realistic goal for recruitment is over time."

Postmarketing surveillance: FDA said that it is just getting started with postmarketing surveillance, and it is going to be one of the agency's greatest challenges. The charge is to obtain access to and to build a bridge between disparate data coming from private and public records.

"Electronic medical records are only as good as the record itself," Kwedar said. "What is it we are looking for? With what technology are we going to do this and how? Postmarketing surveillance has to be a collaborative effort, and we must rely on partnerships with industry, academia and the private/public sector."

Resource Allocation
So how much will it cost to implement FDAAA? A lot. "Our staff is stretched beyond capacity, and when you add this Goliath to the mix, it is pretty daunting," Kweder said. "Money doesn't translate to new capacity. People have to be trained, and FDA is the best training camp for FDA work. Just bringing in more bodies isn't going to makes us meet capacity."

She also told the audience that many FDA employees are working double-duty handling FDAAA and other responsibilities. "This is a sea of change, as long as we have people competent and trained to do the job and [can] train others to do the job," said Professor Hugh Tilson of the University of North Carolina in closing.

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