‘Outrageous giveaway to Big Pharma’: A political ‘bomb’ over drug prices may threaten NAFTA 2.0

https://www.japantimes.co.jp/news/2019/02/13/business/outrageous-giveaway-big-pharma-political-bomb-drug-prices-may-threaten-nafta-2-0/#.XGR6YlVKi1s

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The clash over free trade in North America has long been fought over familiar issues: low-paid Mexican workers. U.S. factories that move jobs south of the border. Canada’s high taxes on imported milk and cheese.

But as Democrats in Congress consider whether to back a revamped regional trade pact being pushed by President Donald Trump, they’re zeroing in on a new point of conflict: drug prices. They contend that the new pact would force Americans to pay more for prescription drugs, and their argument has dimmed the outlook for one of Trump’s signature causes.

The president’s proposed replacement for the 25-year-old North American Free Trade Agreement is meant to win over Democrats by incentivizing factories to hire and expand in the United States. Yet the pact would also give pharmaceutical companies 10 years’ protection from cheaper competition in a category of ultra-expensive drugs called biologics, which are made from living cells.

Shielded from competition, critics warn, the drug companies could charge exorbitant prices for biologics.

“This is an outrageous giveaway to Big Pharma,” Rep. Rosa DeLauro, a Connecticut Democrat, said in an interview. “The government guarantees at least 10 years of market exclusivity for biologic medicine. It’s a monopoly. It’s bad policy.”

The objections of DeLauro and other Democrats suddenly carry greater potency. The need to curb high drug prices has become a rallying cry for voters of all political stripes. Trump himself has joined the outcry. The revamped North America trade deal must be approved by both chambers of Congress, and Democrats have just regained control of the House.

Rep. Earl Blumenauer of Oregon, the new chairman of the House Ways and Means subcommittee on trade, told The Associated Press that “I don’t think candidly that it passes out of my trade subcommittee” with the biologics provision intact.

“The biologics are some of the most expensive drugs on the planet,” Blumenauer said.

Still, the politics of NAFTA 2.0 are tricky for Democrats and not necessarily a sure-fire winner for them.

The original NAFTA, which took effect in 1994, tore down most trade barriers separating the United States, Canada and Mexico. Like Trump, many Democrats blamed NAFTA for encouraging American factories to abandon the United States to capitalize on lower-wage Mexican labor and then to ship goods back into the U.S., duty-free.

Having long vilified NAFTA, Trump demanded a new deal — one far more favorable to the United States and its workers. For more than a year, his top negotiator, Robert Lighthizer, held talks with Canada and Mexico. Lighthizer managed to insert into the new pact provisions designed to appeal to Democrats and their allies in organized labor. For example, 40 percent of cars would eventually have to be made in countries that pay autoworkers at least $16 an hour — that is, in the United States and Canada and not in Mexico — to qualify for duty-free treatment.

The new deal also requires Mexico to encourage independent unions that will bargain for higher wages and better working conditions.

Late last year, the three countries signed their revamped deal, the U.S.-Mexico-Canada Agreement. But it wouldn’t take effect until their three legislatures all approved it. In the meantime, the old NAFTA remains in place.

The question now is: Are Democrats prepared to support a deal that addresses some of their key objections to NAFTA and thereby hand Trump a political victory? Some Democrats have praised the new provisions that address auto wages, though many say they must be strengthened before they’d vote for the USMCA.

Protection for drug companies is another matter. Many Democrats had protested even when the Obama administration negotiated eight years of protection for biologics— from cheap-copycat competitors called “biosimilars” — in a 12-country Pacific Rim trade pact called the Trans-Pacific Partnership, or TPP.

Trump abandoned the TPP in his first week in office. But the pharmaceutical industry is a potent lobby in Washington, and Trump’s negotiators pressed for protection for U.S. biologics in the new North American free trade deal. They ended up granting the drug companies two additional years of protection in the pact.

Top biologics include the anti-inflammatory drug Humira, the cancer fighter Rituxan and Enbrel, which is used to treat rheumatoid arthritis.

The administration and drug companies argue that makers of biologics need time to profit from their creations before biosimilars sweep in, unburdened by the cost of researching and developing the drugs. Otherwise, they contend, the brand-name drug companies would have little incentive to invest in developing new medicines.

They note that a 2015 law authorizing presidents to negotiate trade deals requires American officials to push other countries toward U.S.-level protections for intellectual property such as biologic drugs. (The same law, somewhat contradictorily, directs U.S. negotiators to “promote access to medicines.”)

Supporters also note that existing U.S. law gives makers of biologics 12 years’ protection. So the new pact wouldn’t change the status quo in the United States, though it would force Mexico to expand biologics’ monopoly from five years and Canada from eight years. In fact, supporters of the biologics monopoly argue that the pact might cut prices in the United States because drug companies would no longer face pressure to charge Americans more to compensate for lower prices in Canada and Mexico.

But critics say that expanding biologics’ monopoly in a trade treaty would prevent the United States from ever scaling back the duration to, say, the seven years the Obama administration once proposed.

“By including 10 years in a treaty, we are locking ourselves in to a higher level of monopoly protection for drugs that are already taking in billions of dollars a year,” said Jeffrey Francer, general counsel for the Association for Accessible Medicines, which represents generic drug companies. “The only way for Congress to change it is to back out of the treaty. … Does the United States want to be in violation of its own treaty?”

For Democrats, higher drug prices are shaping up as a powerful political argument against approving the president’s new North American trade deal. In December, Stanley Greenberg, a leading Democratic pollster and strategist, conducted focus groups in Michigan and Wisconsin with Trump voters who weren’t affiliated with the Republican Party. Some had previously voted for Barack Obama. Others called themselves political independents. They’re the kinds of voters Democrats hope to attract in 2020.

Greenberg said he was “shocked” by the intensity of their hostility to drug companies — and to the idea that a trade pact would shield those companies from competition.

“It was like throwing a bomb into the focus group,” said Greenberg, who is married to DeLauro. He said the voters’ consensus view was essentially: “The president was supposed to go and renegotiate (NAFTA) so that it worked for American workers. But it must be that these lobbyists are working behind the scenes” to sneak in special-interest provisions.

That perception gives Democrats reason to reject the new pact as the 2020 election approaches.

“Democrats have no incentive to do this,” said Philip Levy, a senior fellow at the Chicago Council on Global Affairs and a White House economist under President George W. Bush. “Before you know it, the presidential election season is going to be upon us.”

U.S. trade rules are designed to force Congress to give trade agreements an up-or-down vote — no nitpicking allowed. Still, there are ways to bypass those restrictions. Congressional Democrats could, for example, push the administration to negotiate so-called side letters with Canada and Mexico to address their concerns. President Bill Clinton did this with the original NAFTA.

“Lighthizer and his team are very creative,” said Blumenauer, chair of the House trade subcommittee. “This is something that can be handled.”

 

 

 

Forty Years of Winning Friends and Influencing People

https://www.chcf.org/blog/forty-years-of-winning-friends-and-influencing-people/

An interview with former US Representative Henry Waxman of California.

Of the more than 12,000 Americans who have served in Congress since it convened in 1789, few have had careers as fruitful as Henry Waxman’s. Representing west Los Angeles and its surrounding areas for 40 years, Waxman, 78, left a remarkable imprint on US health policy. His manifold accomplishments were capped by the passage of the Affordable Care Act (ACA) in 2010. A son of south-central Los Angeles, he worked at his father’s grocery store, earned a law degree at the University of California, Los Angeles, and in 1968 won a seat in the State Assembly. He was elected to the US House in 1974 in an era when bipartisanship was ordinary and health care had yet to become an overwhelming economic and political force in American life. Waxman was known in Congress for his persistence at wearing down opposition. Republican Senator Alan Simpson of Wyoming famously called him “tougher than a boiled owl” after negotiating the landmark Clean Air Act amendments of 1990. Waxman led efforts to ban smoking in public places and to require nutrition labels on food products. I talked with him recently about his experiences, the future of health policy, and the changing language of health reform. The transcript has been lightly edited for length and clarity.

Q: In 1974, when Los Angeles voters first sent you to Washington, health policy wasn’t the ticket to political influence. You are a lawyer, not a doctor. What drew you to health care?

A: When I was first elected to the California State Assembly in 1968, I believed that if I specialized in a policy area I would have more impact than if I tried to be an expert on everything. Health policy fit my district in Los Angeles, and I could see that government needed to be involved in a whole range of decisions, from health care services to biomedical research to public health. I was chairman of the Assembly Committee on Health. I was elected to Congress in 1974 in a Democratic wave election. I wanted to get on a health policy committee, which was Energy and Commerce. Democrats picked up so many seats and there were so many committee vacancies that year that it was easy to claim one, and I got on that committee. Within four years there was a vacancy for chair of the health and environment subcommittee, and I stepped up to that. It gave me a lot more impact.

Q: What role do you think health care will play in the upcoming elections?

A: If the Democrats do as well as I expect and hope, it will be more because of what Trump was doing in the health area than anything else. Even though people value health care services and insurance, the idea that the president and the GOP wanted to take away health insurance and reduce benefits for people who needed it — that was something they didn’t expect and were angry about.

Q: Is it feasible to provide health coverage to everyone?

A: I have always felt we needed access to universal health coverage. It wasn’t until we got the ACA under Obama that we were able to narrow the gap of the uninsured — those who couldn’t get insurance through their jobs, who weren’t eligible for Medicare and Medicaid, who had preexisting conditions, or who couldn’t afford the premiums. The ACA helped people have access to an individual health policy by eliminating insurance company discrimination and giving a subsidy to those who couldn’t afford coverage. It wasn’t a perfect bill, but it was important. The idea that Republicans would come along and bring back preexisting conditions as a reason to deny people coverage is what drove enough GOP senators to stop the GOP repeal bill from going forward last year. We’ll see what they do by way of executive orders or through the courts to try to frustrate people’s ability to buy insurance.

The Republican ACA repeal bill last year was a real shock because they also wanted to repeal the Medicaid program and allow states to cut funds for people in nursing homes, people with disabilities, and low-income patients who rely so heavily on that program. And they had proposals to hurt Medicare that House Speaker Paul Ryan had been advancing. The American people do not want to deny others insurance coverage and access to health services.

Q: Bipartisanship has gone out of style. Can it be revived?

A: It doesn’t look very likely now, but I built my legislative career on the idea that there could be bipartisan consensus to move forward on legislation. All the big bills had bipartisan support. The only bill that got through on a strictly partisan basis was the Obamacare legislation, and I regretted that. The Republicans just wanted to denigrate it and scare people into believing the ACA would provide for death panels, hurt people, take away their insurance, and keep them from getting access to care. None of that was true.

Q: A growing number of Democrats want to establish a single-payer health care system for the state. Do you agree with them?

A: A lot of people mistake the phrase “single payer” with universal health coverage. While I share the passion of people who want to cover everybody, single payer is not a panacea. My goal is universal health coverage. The Republican attempt last year to repeal the ACA and send 32 million Americans into the ranks of the uninsured was an albatross around their necks.

But the Democrats could turn this winning issue into a loser if some make a single-payer bill such as Medicare for All into a litmus test. I cosponsored single-payer legislation in Congress with Senator Ted Kennedy, and I always sought to bring the nation closer to universal coverage. I authored laws to bring Medicaid to more children and to establish the Children’s Health Insurance Program, and I led the fight to enact the ACA. These bills were very important. If we passed something like a single-payer bill, which would be extremely hard to do, we would be passing up opportunities to make progress. A lot of people who want a Medicare for All bill don’t realize that those of us on Medicare have to pay for supplemental insurance, because Medicare doesn’t cover everything. Medicare doesn’t generally cover certain services like nursing home care, so to get help you have to impoverish yourself to qualify for Medicaid.

One organization is sending out letters telling voters to support a single-payer bill and you won’t have to pay anything anymore. We can’t afford something like that. Democrats can embrace a boundless vision for a health care future without being trapped by a rigid model of how to get there. We should increase the number of people with comprehensive health insurance and focus on lowering costs. People with Medicare don’t want to give it up. People have health insurance on the job.

I would rather expand on what we have and build it out to cover everybody.

People don’t seem to remember that Democrats could barely muster the votes for the ACA when we had 60 votes in the Senate and a 255–179 majority in the House. Even if we recapture Congress and the presidency, I don’t think we would get a Medicare for All bill passed. It would require such a high tax increase that people would be absolutely shocked.

Q: What would be the national impact of California adopting a universal coverage plan?

A: Californian progress would be a model for the rest of the country, and we would be doing what’s right for the people of California who don’t have access to coverage. I think California is a trendsetter — for good and for bad. Proposition 13 and term limits started in California and spread to other states, and I think they have been a disservice. We’ve also done a lot of good things in California, and the rest of the country follows those things as well.

People who try to marginalize California do so at their own risk. People around the country look at California as a leader. California embraced the ACA, expanded Medicaid, and has been moving forward on making sure our public health care system is reforming itself to represent the needs for population health care and to ensure that uninsured low-income patients get access to decent, good-quality health care.

Q: More states are adopting work requirements in Medicaid. Do you think that will become the standard nationwide?

A: Work requirements are inconsistent with the Medicaid law. We’re talking about making people go to work to get health care when they’re sick. I just don’t think it makes sense. The courts may throw it out, and if not, at some point there will be a reaction against it, and it will be repealed by a future Congress.

Q: Some see parallels between the conduct of tobacco companies and opioid makers. Do you think “Big Pharma” will be held to account like “Big Tobacco?”

A: In the difficult fight against big tobacco, one of the lessons we learned was that even an extremely powerful group like the tobacco industry could be beaten if you keep pushing back. Even though there was overwhelming public support for regulation of tobacco, it took until 2009 before we could enact tobacco regulation by giving the Food and Drug Administration (FDA) authority to act. In the meantime, there were lawsuits by states to recover money they spent under Medicaid programs to cope with the harm from smoking. With opioids, there will be more and more lawsuits against distributors and manufacturers whose actions resulted in deaths of people from opioid addiction. Congress now is grappling with many bills to help people who are addicted, to prevent addiction from spreading further, and to restrict the ability to get the drug product. I’m optimistic we can come to terms with this crisis.

Q: What have you been doing since retiring from Congress?

A: I wanted to stay in the DC area near my son, Michael Waxman, and his family. He had a traditional public relations firm and he asked me to join him. In the health area, we represent Planned Parenthood in California, public hospitals in California, community health centers at the national level, and hospitals that get 340b drug discounts because they serve many low-income patients. We have foundation grants to work on problems of high pharmaceutical prices, and foundation grants to have a program to make sure women know about the whole range of health services available to them for free under the ACA. I enjoy working with my son and pursuing causes I would have pursued as a member of Congress.

 

 

 

How Pharma Companies Game the System to Keep Drugs Expensive

https://hbr.org/2017/04/how-pharma-companies-game-the-system-to-keep-drugs-expensive?utm_campaign=hbr&utm_source=facebook&utm_medium=social

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I help the University of Utah hospital system manage its drug budgets and medication use policies, and in 2015 I got sticker shock. Our annual inpatient pharmacy cost for a single drug skyrocketed from $300,000 to $1.9 million. That’s because the drug maker Valeant suddenly increased the price of isoproterenol from $440 to roughly $2,700 a dose.

Isoproterenol is a heart drug. It helps with heart attacks and shock and works to keep up a patient’s blood pressure. With the sudden price increase, we were forced to remove isoproterenol from our 100 emergency crash carts. Instead, we stocked our pharmacy backup boxes, located on each floor of our hospitals, to have the vital drug on hand if needed. We had to minimize costs without impacting patient care.

This type of arbitrary and unpredictable inflation is not sustainable. And it’s not the way things are supposed to work in the United States. Isoproterenol is a drug that is no longer protected by a patent. Theoretically, any drug company should be able to make a generic version and sell it at a competitive cost. We should have had other options to buy a competitors’ copy for $440 or less. But that’s not happening like it should. The promise of generic medications is getting further from reality each day. As the U.S. Senate considers President Donald Trump’s choice to head the Food and Drug Administration, now is the time refocus efforts on generic drugs.