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Capitol Checkup: Barring Congress from boards; standardizing drug safety reviews


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Capitol Checkup: Barring Congress from boards; standardizing drug safety reviews

Two New York members of Congress — one Republican and one Democrat — want all lawmakers on Capitol Hill barred from serving on the boards of publicly traded companies following the arrest last week of one of their colleagues, Rep. Chris Collins, R-N.Y., on insider trading charges.

Reps. Kathleen Rice, D-N.Y., and Tom Reed, R-N.Y., want to change the House rules to match those already employed by the U.S. Senate, which strictly prohibits members of that chamber from serving on the boards of any publicly held or publicly regulated corporation, financial institution or business entity.

"There should never be a doubt in the public's mind to lead them to think their representative could be corrupted or incriminated because of their stake or position in a private company," Rice and Reed stated. "We owe the American people this fair assurance."

Meanwhile, Democrats are calling for Collins — a key supporter of President Donald Trump — to immediately leave Congress rather than waiting for the end of his term in January.

Three days after Collins pleaded not guilty to charges he tipped his son to insider information about the failure of Innate Immunotherapeutics Ltd.'s study of its multiple sclerosis drug, the New York congressman revealed on Aug. 11 he would no longer seek re-election. He disclosed the news after initially insisting he would remain on the ballot and not step aside.

House Minority Leader Nancy Pelosi, D-Calif., called on House Speaker Paul Ryan, R-Wis., to force Collins to resign.

"No person is above the law — not the president nor his first supporter in Congress," Pelosi said.

During an Aug. 11 press conference, Collins' Democratic opponent, Nate McMurray, also said the lawmaker should resign, arguing that New York's 27th congressional district needed a "clean break from this era of dark politics and corruption, of backroom deals."

Democrats have made corruption in Washington one of the key planks of their plan to try to take control of Congress — arguing Trump has failed in his pledge to "drain the swamp."

Instead of doing that, Trump built a hotel on the swamp and "pocketed $40 million from it," Rep. Cheri Bustos, D-Ill., told reporters during an Aug. 9 briefing, referring to the Old Post Office building in Washington that the General Services Administration leased to the president's holding company, which opened a hotel on the property in 2016.

During the call, Bustos did not give a full-throated endorsement to the Rice-Reed measure to ban lawmakers from serving on a corporate board, only saying it was "probably not" a good idea to be a board director while in Congress.

Rep. John Sarbanes, D-Md., also did not say whether he supported the bipartisan resolution — saying that participating on company boards could be "potentially problematic."

Both Democrats, however, said Collins' arrest revealed a larger problem with a lack of ethics in Washington, particularly at the Trump White House.

The fact Collins was accused of making the call from the White House in which he allegedly tipped off his son about Innate's study revealed the New York congressman thought he was in an "ethics-free zone," Sarbanes said.

FDA plans to standardize drug safety assessments

The U.S. Food and Drug Administration plans to standardize its drug safety assessments — a move the agency's commissioner said would create more efficiency and provide more transparency about regulators' approach.

The effort is part of the FDA's overhaul, first revealed in June, of its office that evaluates new medicine applications and its review processes, Commissioner Scott Gottlieb said during an Aug. 10 Washington forum hosted by the National Health Council, a patient advocacy group.

"We're probably going to be speaking more about this in October," Gottlieb said. "We are going to be rolling out a comprehensive standardized assessment for drug safety where we are going to take the information the companies submit and rather than just looking at drug safety parameters in terms of the tables that are submitted to us, we are actually going to take the raw data and reevaluate it into custom tables that the agency's going to develop that's going to be standardized across all our review divisions to create a more structured approach to how we evaluate drug safety questions."

Currently, when a biopharmaceutical company submits a marketing application to the FDA, the reviewer who has primary control of the package manipulates the data using their own preferences into different tables and formats to conduct their assessment, the commissioner said.

"They shouldn't be doing that. It's not an efficient use of their time," Gottlieb said, acknowledging the FDA's inconsistent output in its review packages.

Under the FDA's revised process, its clinical reviewers will see a standardized assessment of data in which the information already has been interrogated and manipulated by people who are experts, the commissioner said.

"We are creating an actual function of people who have analytical capability and manipulate data for a living to actually take on this role to support the clinical reviewers," Gottlieb said. "It's going to create a lot of efficiency in the review process and free up reviewers to engage the community more."

The result of the change will be a more consistent approach that ultimately will be seen in the output of the FDA's assessment, he said.

The new standardized process is expected to "lend itself to more transparency around our approach, because right now, since we don't have a standard approach, you don't know the approach," the FDA chief said.

Gottlieb said the FDA also is continuing to work on incorporating real-world evidence and patient-reported data into its assessments — following up on a vow he made last year.

Real-world evidence is derived from a variety of sources, like electronic health records, billings and claims databases and product and disease registries, according to the FDA.

Gottlieb noted the FDA plans to hold a two-day meeting in mid-October on patient-focused drug development.

"One of the primary goals that I have is to build as much structure into the drug review process for measurement of the outcomes and other clinical measures that are important to patients, that measure the way patients experience disease, experience treatments," Gottlieb said. "If we're going to make a meaningful impact in terms of trying to build into drug development measures of how things are actually happening in patient care, the way to do that is to do it on a structured basis."

While the culture at the FDA has changed — with more acceptance of using real-world evidence and patient-reported outcomes — Gottlieb said he would like to see the new principles diffused more widely across all divisions at the agency.

Economic concerns raised over removing PBM safe harbor protections

The Republican leaders of two key congressional committees raised concerns last week about the potential economic impacts of the Trump administration's proposed rule to eliminate the safe harbor protections that allow pharmacy benefit managers, or PBMs, and health plans to secure rebates from drugmakers.

The proposed rule has been under review at the White House Office of Management and Budget, or OMB, since about mid-July.

"Depending on the nature of the policies contemplated, possible changes could ripple across the healthcare sector, altering a major sector of the U.S. economy that Americans depend upon for their health and well-being," Senate Finance Committee Chairman Orrin Hatch, R-Utah, and House Energy and Commerce Committee head Greg Walden, R-Ore., said in an Aug. 9 letter to OMB Director Mick Mulvaney.

The lawmakers called for a "robust regulatory impact analysis" of the proposed rule before the OMB clears it for publication.

On May 11, Trump said he wanted to eliminate PBMs, though some key proposals in his strategic plan to lower drug prices rely on those companies for the measures' success, including a recently announced move to step therapy, in which the government's Medicare Advantage program would require seniors and the disabled to use cheaper medicines before they can try more expensive drugs administered in doctors' offices or outpatient facilities.

CDC targets flu in graphic novel

The Centers for Disease Control and Prevention last week unveiled a new graphic novel with the aim of educating America's youth about infectious diseases, including influenza.

The new comic book coincides with the CDC's latest FluView report, which detailed information about four new variant influenza virus infections associated with attendance at agricultural fairs in Michigan and California.

Most variant flu infections occur in children exposed to infected pigs or their environments in agricultural fair settings, according to the CDC. While variant flu infections in people are rare, they can sometimes lead to serious illness, including hospitalization and death.

During 2017, 67 variant virus infections were reported in the U.S., six of which resulted in hospitalization, including two children who were admitted into an intensive care unit.