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Capitol Checkup: 'It's healthcare, stupid,' in 2018; progress on cheaper drugs

While the economy remains a high priority for American voters ahead of the November midterm elections, new polls show healthcare has either outranked or tied even with that issue as their most important concern.

That turn of events has some in Washington recycling and replacing Democratic political strategist James Carville's famous 1992 slogan about the economy with "It's healthcare, stupid" for 2018.

An Oct. 14 CBS News poll of 4,831 registered voters found that 70% of the respondents said healthcare would be very important when they cast their votes for members of Congress next month, though the economy came in a close second at 67%. Other top issues were taxes, immigration, the Supreme Court and gun policy.

Only 2% of the respondents said healthcare was not important, while 23% said it was somewhat important.

If Democrats win the House and Senate, 42% of those surveyed by CBS News said the party would make healthcare better, while 47% said if Republicans kept control, they would make it worse.

Based on its poll, CBS News estimated Democrats would win the House with 226 seats — more than the 218 needed to capture the chamber — versus 209 for the Republicans.

Using additional models, CBS News determined Democrats could take as many as 235 seats under a higher turnout scenario, Anthony Salvanto, the network's director of elections and surveys, said on the Sunday political program "Face the Nation."

But if Democrats have a low turnout, Republicans could retain the House, Salvanto added.

An Oct. 14 ABC News-Washington Post poll found that 82% of the 1,144 adults surveyed put healthcare dead even with the economy as their most important issues of concern.

The poll also showed that more Americans trust Democrats than Republicans to handle healthcare — 53% versus 35%, respectively.

In general, more Americans in the ABC News-Washington Post survey said they trust Democrats over Republicans to handle the main problems facing the U.S. — 45% compared with 37%.

An Oct. 12 Politico-Harvard School of Public Health survey of 1,201 likely voters found that healthcare ranked the highest in importance for issues that would decide how the respondents voted for House members — with 40% saying it was extremely important, over 39% voted for gun policy, 38% for Supreme Court nominations, 37% for the economy and jobs and 37% for education — though the pollsters considered the results of those five issues a statistical tie.

Priorities differed dramatically, however, among the list of 15 issues the respondents to the Politico-Harvard survey were asked to rank as their most important.

Healthcare was the top issue for Democrats overall in the survey, with 55% of the likely voters from that party saying it was extremely important. But it was not among the top five issues of importance overall for Republicans, who ranked terrorism, the economy and jobs, gun policy, immigration and taxes as their key concerns, respectively.

For the Democrats and Republicans who put healthcare as their top issue, 73% said making sure insurers continue to provide coverage for pre-existing conditions — a protection granted under the Affordable Care Act — was extremely important.

In recent months, a number of Republicans running for Congress who voted to repeal the ACA or who are plaintiffs in a case challenging the law's pre-existing conditions protections have backtracked in their political campaigns, claiming in speeches and advertisements that their earlier actions were meant to do just the opposite.

Rep. Dave Brat of Virginia is among the Republicans to make such a claim, even though in May 2017 he had voted in favor of giving states the option to allow insurers to charge higher premiums to patients with pre-existing conditions.

Lowering healthcare and prescription drug costs

The Politico-Harvard poll also found that 69% of respondents said lowering the overall cost of healthcare was extremely important, though it ranked much higher for Republicans than Democrats.

Lowering prescription drug prices was also of greater importance to Republicans than Democrats among healthcare issues of concern.

But more than half the respondents overall, or 52%, said they did not expect President Donald Trump's strategic plan to lower drug prices to make a difference.

Trump has yet to implement most of the blueprint's proposals, though there has been speculation that the administration could act as soon as Oct. 15 on one of its promises — requiring drugmakers to include their list prices in direct-to-consumer advertising.

Analysts had surmised that a Health and Human Services proposal that was under review by the White House Office of Management and Budget since Aug. 21 — Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency — was intended as the pathway to put the advertisement requirement into place.

"While we cannot comment on pending regulations, the president's 'American Patients First' blueprint to lower prescription drug prices and reduce out-of pocket costs clearly states that HHS is looking at options to require drug pricing transparency. It should not come as a surprise that this would require rulemaking," HHS spokeswoman Caitlin Oakley told S&P Global Market Intelligence in an Oct. 12 emailed response.

The administration is also seeking to remove the safe harbor protections that allow pharmacy benefit managers and health plans to secure rebates from drugmakers — another proposal that has been under review at OMB since about mid-July.

Oakley gave a similar response to questions from S&P Global Market Intelligence about that pending rule.

She also weighed in last week on reports that HHS Secretary Alex Azar may be under consideration to replace Jeff Sessions as U.S. attorney general, if he leaves or Trump fires him.

"Secretary Azar has repeatedly said that this is the best job he has ever had and that this is his dream job," Oakley said. "He plans to continue serving President Trump as his HHS secretary."

US FDA progress on cheaper drugs

Meanwhile, U.S. Food and Drug Administration Commissioner Scott Gottlieb said his agency had tentatively approved or cleared a record 971 lower-cost generic drugs during fiscal year 2018, which ended on Sept. 30, breaking the previous record of 937 from last fiscal year.

The FDA stands to also possibly break the calendar-year record of 1,027 generic approvals set in 2017.

"When I started as FDA commissioner, I made clear that one of my top priorities would be ensuring the agency does all it can to help ensure American patients have access to affordable, quality medicines that meet their needs," Gottlieb said in an Oct. 12 statement to S&P Global Market Intelligence.

He said the FDA also is continuing to focus its efforts on helping makers of generic versions of more complex drugs, like Mylan NV's emergency anaphylaxis medicine EpiPen, get their products to the U.S. market.

"In too many cases, there is no generic competition for these costly branded drugs even after they have lost their exclusivity protections," Gottlieb said.

In a series of tweets on Oct. 14, Gottlieb outlined some of the steps the FDA has taken to try to bring complex generics to the market quicker and said the agency would soon advance additional policies to further that effort.

But FDA approvals do not necessarily mean those products have made their way to the U.S. market. Some companies, like Teva Pharmaceutical Industries Ltd with its version of EpiPen, have run into delays with marketing with their complex generics, while other manufacturers have entered into agreements with brand-name drugmakers to postpone the market entrance of the cheaper products.

Biosimilars — medicines intended to be lower-cost versions of biologic therapies, which are drugs derived from natural sources, such as microorganisms or plant or animal cells — also have faced delays in coming to the U.S. market.

While the FDA has approved 12 biosimilars, only four are currently being marketed in the U.S.

Nonetheless, a number of companies are continuing to pursue biosimilars, according to the FDA.

As of Oct. 1, there were 63 projects enrolled in the FDA's Biosimilar Product Development program and the agency had received meeting requests to discuss the development of the lower-cost products for 31 different referenced innovator biologic medicines, a spokeswoman told S&P Global Market Intelligence.

Celltrion Pharm Inc. and its partner Teva are hoping to be the first to bring a biosimilar version of Roche Holding AG's non–Hodgkin lymphoma drug Rituxan to the U.S. market after gaining a positive review by the FDA and a recommendation from an advisory committee last week.

"Biosimilars are the great experiment," Joseph Fuhr, a professor emeritus at Widener University, told the FDA at the Oct. 10 advisory committee meeting where Celltrion's application was reviewed.

But, if biosimilar competition does not work, the result could be price controls, Fuhr said.

"This could decrease the incentive to innovate and lead to fewer drugs being developed, which will hurt consumers," he said.