A new pro-brand-name biopharmaceutical industry group that drew much speculation after its initial launch revealed late last week who was running the organization, but details about its funding remain unclear.
In an Oct. 5 statement posted on the Alliance to Protect Medical Innovation's website, former journalist Patrick O'Connor, a partner at CGCN Group, a lobbying organization, said he is the new entity's executive director. He said APMI was "never intended to live in the shadows," noting it has a website and has sought to engage with news reporters.
"I believe there has never been a greater need to bring balance to the discussion around the issues of healthcare costs and medical innovation," O'Connor said.
He said APMI's objective was to "highlight the power of medical innovation and the importance of that innovation to patients, while also taking a look at the coordinated and well-funded efforts to fuel much of the current narrative around medical innovation."
O'Connor insisted the conversation on drug prices and healthcare costs has been a "little one-sided, so we would like to serve as a counter-balance where possible."
In an inaugural press release sent last week to certain news publications, including S&P Global Market Intelligence, APMI said it was formed as a "nonpartisan" nonprofit organization to help educate policymakers and the public about medical breakthroughs.
But it also said it intended to act as a "fact-check" on groups promoting "dangerous policies that will limit biomedical innovation."
It took particular aim at the Arnold Foundation, saying it has a "$48 million web of influence" and has funded groups like the Institute for Clinical and Economic Review, the Patients for Affordable Drugs and ProPublica.
Before O'Connor revealed his connection to APMI, John Arnold, founder and co-chair of the Arnold Foundation, called out APMI on Twitter and said it should "come out of the shadows so we can debate the issues."
Arnold noted that his organization's funding has been transparent, while APMI's was not.
While APMI made clear through a series of statements last week on its website that its intent is to defend the brand-name drug industry, it said it was not a front organization for the big pharma lobbying group, the Pharmaceutical Research and Manufacturers of America, and has not taken any money from it.
Robert Zirkelbach, executive vice president of public affairs at PhRMA, confirmed on Twitter that his organization has "nothing to do with this coalition."
Another brand-name industry lobbying group, the Biotechnology Innovation Organization, however, acknowledged in a statement last week that it had joined APMI.
"Small company innovators are at the center of the biopharmaceutical industry, and they will be disproportionately impacted by the flawed policies often touted as the way to lower the cost of prescription drugs," BIO stated. "Innovation and bad public policy cannot coexist. That's an important message often neglected in the debate about healthcare costs and that's precisely the message this organization will help deliver."
APMI said it currently does not have "a lot of funders to reveal," but admitted it was "given some seed money from people inside the industry."
"Our aim is to add as many people, from as many walks of life, as possible," the group said. "And when we do, we will start disclosing those names."
PhRMA argues trade, drug prices unrelated
Meanwhile, PhRMA and BIO weighed in on President Donald Trump's new trade deal with Mexico and Canada.
The three-way deal, which must obtain U.S. congressional approval, would provide 10 years of data protection for biologic therapies and expand the scope of products eligible to be shielded against competitors.
PhRMA called it a "significant step toward leveling the playing field with our trading partners by delivering strong [intellectual property] protections for American manufacturers and innovators."
"Strong and dependable intellectual property standards are critical to fueling innovation, attracting investment and ensuring that patients, farmers and consumers around the globe have access to the next generation of biotechnology breakthroughs," BIO added in an Oct. 4 statement.
PhRMA noted that, if ratified, the agreement would far exceed intellectual property standards in any other international trade deal.
But makers of lower-cost versions of biologic therapies, or biosimilars, have argued the agreement would stifle their industry, leading to less competition and sustaining the monopoly held by brand-name companies.
The deal also goes against Trump's repeated vows to lower drug prices, the Association for Accessible Medicines noted.
While U.S. law provides 12 years of exclusivity protection for biologic therapies, the trade agreement would lock the nation into at least 10 years, meaning lawmakers would be unable to lower the length of time below that number, like some Democrats have sought.
It also would have an impact on the prices of biologic medicines and biosimilar competition in Canada and Mexico.
PhRMA spokeswoman Megan Van Etten, however, suggested trade agreements and drug prices were unrelated.
"I'm wondering what you mean relating the trade deal to drug price efforts," Van Etten wrote in an email to S&P Global Market Intelligence. "Nothing in this agreement changes U.S. law as it relates to our industry; that's not the intent of international trade deals."
Association for Accessible Medicines President and CEO Chip Davis remarked in a tweet that Van Etten "Must. Be. Kidding."
Republicans backtrack on Affordable Care Act protections
After years of trying to repeal and replace the Affordable Care Act, some Republicans are now backtracking and trying to convince their constituents ahead of the November 2018 midterm elections that the lawmakers were not out to end the law's insurance protections for patients with pre-existing conditions.
Rep. Pete Sessions, R-Texas, chairman of the House Rules Committee, is one the latest Republicans to make the claim, introducing legislation last week he said would preserve the pre-existing conditions protections.
In 2013, Sessions said he was leading the charge to fully repeal the ACA, which he called a "train wreck."
Sessions also was among the Republicans who voted last year in favor of the House repeal-and-replace bill, which would have permitted states to receive waivers that would allow insurers to charge more for patients with pre-existing conditions — legislation that was never adopted by the Senate.
Last week, the Cook Political Report called the race for the 32nd district in Texas a toss-up between Sessions and his Democratic challenger Colin Allred.
Rep. Dana Rohrabacher, R-Calif., also in a toss-up race, according to Cook, is another Republican who voted to repeal the ACA but is now saying he wants to ensure pre-existing conditions protections remain in place.
Last week, he released an ad saying that for him, the pre-existing conditions issue was personal because his daughter, who is featured in the commercial, was a leukemia survivor.
One of the most striking political ads from a Republican came last week from Missouri Attorney General Josh Hawley, who is trying to unseat Democrat Sen. Claire McCaskill.
Hawley is among 20 Republican attorneys general challenging the constitutionality of the ACA, particularly the pre-existing conditions protections, in a lawsuit currently before the U.S. District Court for the Northern District of Texas.
But in his ad, Hawley told Missouri voters the pre-existing conditions issue hits home for him, since he has a son with a rare disease.
"I support forcing insurance companies to cover all pre-existing conditions," he declared in his ad.
Cook's latest ratings also put the McCaskill-Hawley contest at a toss-up.
In recent weeks, Trump has insisted it was the Republicans who have been working to save the pre-existing conditions protections and said the Democrats were trying to end them — a claim Politifact deemed "Pants on Fire" on Oct. 5, meaning it was false.
In late August, a group of Republican senators introduced legislation aimed at ensuring that health insurance plans remained available to Americans with pre-existing medical conditions if the Texas lawsuit invalidated the ACA's protections.
But Larry Levitt, senior vice president for health reform at the nonpartisan, nonprofit Kaiser Family Foundation, said the bill was "something of a mirage," because it would still permit insurers to exclude paying for treatments and services associated with pre-existing conditions.