Consumer groups caution Dems on ‘Cures’ bill

Consumer groups are cautioning against approval of a medical innovation bill moving toward passage in the House and Senate, warning that it could endanger patients by lowering standards for the approval of new drugs. 

Groups like Public Citizen and the National Center for Health Research say the bill, known as 21st Century Cures, would unacceptably lower safety standards at the Food and Drug Administration. 

{mosads}Proponents of the measure, which has been the subject of months of bipartisan negotiations, say it will speed up the FDA’s approval of life-saving new drugs and devices while ensuring that regulatory standards are still strong enough to ensure safety. 

The House is slated to vote on the bill Wednesday, and the Senate is likely to follow soon. A new bill was released Friday night, though it is still undergoing tweaks.

The measure, which is being combined with a less-controversial mental health bill, is a priority for Republican leadership before Congress leaves for the year. 

The consumer groups argue that Democrats are being won over by $4.8 billion in new funding over the next decade for research at the National Institutes of Health. Without this sweetener, they argue provisions loosening FDA regulations would never pass muster on the left. 

“They’ve obviously tried to make this package attractive to many members of Congress by adding increased funding for NIH,” said Dr. Michael Carome, director of the health research group at Public Citizen. 

But he said the bill’s FDA section “endangers public health.”

A number of Democrats are expected to back the bill, but some votes could be lost over concerns about lowering FDA standards. 

Another Democratic concern is that the new NIH funding is no longer mandatory, meaning that it will have to be appropriated each year. That concern is more of an issue in the Senate.

Defenders point out that the funding is still being set aside and protected in the sense that specific ways to pay for it have already been identified and it is in a special fund not subject to the regular budget caps. 

Some FDA experts also favor the bill, and many other groups favor it because of the money for research at the NIH.

Dr. Andrew von Eschenbach, who was FDA commissioner under President George W. Bush, wrote last week that the bill “will reduce the cost and time to bring drugs or devices to market while maintaining product safety.”

The American Cancer Society Cancer Action Network is one of many advocacy groups to praise the bill for its new research funding, specifically for $1.8 billion to fund Vice President Biden’s cancer “moonshot” initiative.

However, the consumer groups opposed to the bill point to provisions that would allow the use of more “real world evidence” of a drug’s effects, which is a lower standard than more rigorous randomized clinical trials. 

The groups, which have long been opposed to the measure, also warn against provisions allowing for companies to submit summaries of data about a drug, rather than the full data set, when seeking to expand the areas for which a drug is approved. 

The bill would also create a faster approval process for “breakthrough” medical devices, which the groups warn would lead the FDA to rush the process. 

Diana Zuckerman, president of the National Center for Health Research, a think tank, said overall the FDA provisions in the bill “make it much easier to get FDA approval for things that may not work and may not be safe.”

Furthermore, there are concerns about such a long bill — almost 1,000 pages — being passed in the lame-duck session of Congress after the elections.

Versions of the bill have been debated for more than a year, but the final language was released just on Friday night. 

“Congress should not rush to pass this nearly 1,000 page bill before there is time to thoroughly review it and understand the public health consequences,” Public Citizen said in a statement. 

The group did note that some provisions it had objected to were removed in the latest version of the bill. 

While most of the attention is on concerns on the Democratic side, Sen. Chuck Grassley (R-Iowa) said Monday he would object to passage of the bill unless a provision is removed that loosens reporting requirements for doctors who receive gifts from drug companies.