(Bloomberg) -- The U.S. Food and Drug Administration and the$110 billion medical device industry held a seriesof private meetings earlier this year to jointly craft a major billthat loosens—wait for it—medical device regulations.

While lobbyists helping write legislation isn't particularlynew, the level of cooperation between regulator and regulated onthe 21st Century Cures bill, revealed in recentlyreleased agency documents, has earned thescorn of some consumer groups.

The law, passed by the House of Representatives, would make iteasier for devices to reach the market and putsafety determinations in the hands of subcontractors paid by devicemanufacturers.

The industry has been under assault in courts across the U.S. assome devices failed and others were used for unapprovedpurposes.

Companies including Boston Scientific Corp., Johnson &Johnson, St. Jude Medical Inc., and Medtronic Inc. have facedthousands of lawsuits and paid hundreds of millions of dollars topatients who suffered sometimes gruesome injuries from faultydevices.

Internal defibrillators to stop heart attacks, hipimplants, mesh to prevent incontinence, and bone-graft productshave all triggered litigation.

Memos released through a public records request describeregular, private meetings between FDA officials and AdvaMed, atrade group, to hash out the text lawmakers eventuallyapproved.

The industry organization spent $2.36 million lobbyingCongress in 2014, according to the Center for Responsive Politics.Meanwhile, legislators held public roundtables about the Cures billfor a year before the vote.

The FDA described the relationship as part of a routineprocess.

But outside observers called the degree of collaborationpeculiar, or worse.

Michael Carome, an opponent of the bill and director of PublicCitizen's health research group, said the meetings showthe FDA has grown too close to the companies it regulates.

“They characterized this as being standard practice. If thistype of collusion is standard practice, that’s alarming,” Caromesaid. "The FDA appears to be bending over backwards to please theindustry and to address their interests above others."

Susan Wood, a former assistant commissioner of women’s health atthe agency who now teaches health policy at George WashingtonUniversity, agreed.

She has also raised concerns about the bill. "FDA draftinglegislation in consultation with outside entities, whoever theyare, strikes me as unusual,” Wood said. "It gives a great deal moreweight to the industry representatives on very specific legislationthat affects both FDA and the industry, and others were not at thattable."

The FDA’s Center for Devices and Radiological Health (CDRH) andAdvaMed "worked together on the proposed language for most of thedevice provisions in'' the Cures Act, according to an FDA memo froma meeting on Aug. 7, a month after the bill passed theHouse.

Robert Califf, who President Barack Obama nominated inSeptember to lead the FDA, was at the meeting, along withAdvaMed officials and executives from Johnson & Johnson and St.Jude Medical.

One former longtime FDA official who requested anonymitysaid such close collaboration was once unheard of.

Others suggested that, rather than bending to the industry'swill, it might have been the agency's best chance to modify a billthat lobbyists could easily push through Congress.

The bill passed with broad bipartisan support.

"The 21st Century Cures legislation came from industry in thefirst place,'' says Mary Pendergast, a former FDA deputycommissioner. "This is part and parcel of the bigger way in whichCongress runs its shop."

While the Cures bill increases funding for the FDA and theNational Institutes of Health, it also makes it easier formanufacturers to get new drugs and devices to market.

The bill allows the FDA to rely on awider range of evidence when approving new devices.

For example, the FDA could consider publishedjournal articles or case studies, rather than reviewing data froman original trial submitted directly to the agency.

Of particular concern to patient advocates is a provision thatwould outsource the job of certifying that changes to ahigh-risk device don't pose a danger.

In other words, instead of going to the FDA to modify thedesign of a pacemaker, manufacturers would go athird-party company paid by the manufacturer to evaluate whetherthe change poses a safety problem.

The Senate is working on a companion bill but hasn’t made thetext public yet. “For the Senate version of 21st Century Cures,[the FDA’s Center for Devices and Radiological Health] is currentlyworking with AdvaMed to refine their regulatory strategy in a waythat is agreeable to both parties,” according to an FDA backgroundmemo for the Aug. 7 meeting.

AdvaMed spokeswoman Wanda Moebius said the creation of the 21stCentury Cures bill was a ``very open and inclusive processcollecting input across the health care community via writtenstatements, town hall meetings, roundtables and hearings." AdvaMedalso disputed that the bill would weaken the "FDA’s robuststandards" and said Congress was ultimately responsible for thecontent of the legislation.

FDA spokeswoman Jennifer Dooren characterized the collaborationas standard procedure.

"FDA officials routinely meet with a diverse group ofstakeholders including industry, patient groups and consumergroups," Dooren said in an e-mail. "Congress regularly asks us fortechnical assistance about how to modify language proposed byoutside groups, as was the case here."

Dooren didn’t respond to questions about whether any othergroups collaborated with the FDA on the text of the proposedbill.

Neither the FDA nor AdvaMed would say how many times the groupsmet.

Spokespeople for Johnson & Johnson and St. Jude Medicaldidn't respond to e-mails seeking comment. The FDA’scollaboration with AdvaMed was first reported last week byInsideHealthPolicy.

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