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Capitol Hill Watch

3. First Zika-Linked U.S. Death Reported; Congress Leaves For Recess Without Approving Funding

Doctors say deaths caused by Zika complications are rare. Meanwhile, lawmakers left several unresolved issues, including a compromise that could allocate more than a billion dollars toward efforts to fight the virus, as they left on a week-long break.

The New York Times: First U.S. Death Tied To Zika Is Reported In Puerto Rico
A Puerto Rican man died from complications of the Zika virus earlier this year, the first reported death attributed to the disease in the United States. The victim, a man in his 70s, died in February from internal bleeding as a result of a rare immune reaction to an earlier Zika infection, according to the Centers for Disease Control and Prevention. Puerto Rico now has 683 confirmed Zika infections in its outbreak, which began in December; 89 are in pregnant women, according to Dr. Ana Ríus, the territory’s health secretary. (McNeil and Victor, 4/29)

The Associated Press: Puerto Rico Reports 1st US Zika-Related Death Amid Outbreak
Officials said the unidentified man recovered from initial Zika symptoms, but then developed a condition in which antibodies that formed in reaction to the Zika infection started attacking blood platelet cells. He died after suffering internal bleeding. [Health Secretary Ana] Rius said the man died less than 24 hours after seeking help at a health center. She said three other cases of the condition known as severe thrombocytopenia have been reported in Puerto Rico, and that those patients recovered successfully. (4/29)

The Hill: First US Zika Death Reported In Puerto Rico
The agency said he developed severe thrombocytopenia, which is a low blood platelet count, but did not give more details. Deaths from Zika are rare, and health officials say symptoms tend to me mild. Many people develop no symptoms at all. The virus is mainly seen as a threat for pregnant women because it is linked to severe birth defects in babies. (Sullivan, 4/29)

The Associated Press: Congress Heads Out With No Resolution On Zika, Puerto Rico
Congress accomplished relatively little in a short work period, missing deadlines on the budget and on helping Puerto Rico with its financial crisis as lawmakers began a weeklong break. They left behind few clues about how they would address must-do items such as finding money to counter the Zika virus and a second, even scarier July 1 deadline for averting a fiscal disaster in cash-strapped Puerto Rico. Democrats called upon House leaders to modify this spring's three-weeks on, one-week off legislative schedule to keep working, as Puerto Rico hurtles toward a half-billion-dollar default on Sunday. (4/30)

The Des Moines Register: A Few Zika-Bearing Mosquitoes Could Buzz Into Iowa
Southern mosquitoes could buzz into Iowa this summer, but state experts don't expect them to be a major carrier of the Zika virus. New maps from the Centers for Disease Control and Prevention show Iowa in the range of one of two mosquito species believed to carry the virus, which causes birth defects. The maps show the Aedes aegypti mosquito’s range ing out in Missouri, but they show the Aedes albopictus mosquito’s range extending through Iowa and into southern Minnesota. (Leys, 4/29)


4. Documents From Senate Hearing Reveal The Driving Force Behind Valeant's Price Hikes

Outgoing CEO J. Michael Pearson went against suggestions from the top leaders in the company to push for aggressive increases, documents show. Meanwhile, The Wall Street Journal takes a look at incoming CEO Joseph Papa's strategy as head of a pharmaceutical company -- and it looks very similar to the course Valeant has set.

The Wall Street Journal: Valeant’s CEO Was Key Force On Pricing
In early 2015, when Valeant Pharmaceuticals International Inc.’s top brass met to set prices on a soon-to-be-acquired cardiac drug, some executives suggested slow, staggered price increases. Chief Executive Michael Pearson disagreed. To reach Valeant’s internal profit targets, Mr. Pearson lobbied for a single, sharp increase. ... The day it completed its February 2015 purchase of the drug, called Nitropress, Valeant tripled the cost. The exchange, recounted in a document reviewed by The Wall Street Journal, shows in greater detail than was previously known how Valeant and its now-outgoing CEO Mr. Pearson pursued quick, aggressive price increases on acquired drugs in recent years—a strategy that sparked widespread backlash and landed Mr. Pearson in front of a Senate investigative panel last week. (McNish and Hoffman, 5/1)

The New York Times: Valeant’s New Skipper Is On The Same Tack
When a deeply troubled company replaces its chief executive, it makes sense to expect the new C.E.O. to bring a fresh take to its operations. A clean sweep, so to speak. But if shareholders in Valeant Pharmaceuticals International envisage a vastly different approach by Joseph C. Papa, the company’s incoming chief executive, they may be disappointed. That’s because in the almost 10 years that Mr. Papa headed Perrigo, a maker and distributor of over-the-counter and generic prescription drugs, the company pursued a series of strategies that were very Valeant-esque. (Morgenson, 4/29)

And the company has filed its long-overdue financial report —

The Wall Street Journal: Valeant Files Overdue Annual Report, Shakes Up Its Board
Valeant Pharmaceuticals International Inc. filed its long-delayed annual report and further reshaped its board Friday, defusing the danger of a debt default and positioning the company for a fresh start after months of concern over its accounting and business practices. But the Canadian drugmaker also disclosed new and broadened regulatory investigations—in addition to the Securities and Exchange Commission probe it already faces—indicating it isn’t out of the woods yet. (Rapoport and McNish, 4/29)

STAT: Board Overhaul, New Probes Disclosed In Valeant Annual Report
After weeks of delay, Valeant Pharmaceuticals on Friday filed its 2015 annual report with regulators, a significant move that will help the beleaguered drug maker avoid default on more than $30 billion in debt. At the same time, the company overhauled its board, shrinking it to 11 members from 14. (Silverman, 4/29)

The Associated Press: Valeant Files Overdue Financial Report, Ending Debt Default
Valeant Pharmaceuticals resolved its default on some of its $30 billion in debt by finally filing its long-overdue U.S. financial report for 2015 on Friday. The badly tarnished Canadian drugmaker also announced a slate of mostly new nominees for elections to its board in June. The moves briefly nudged up Valeant's battered shares, but they quickly headed south amid a broader market sell-off and the realization that the former Wall Street darling's future is still in question. (4/29)

Health Law Issues And Implementation

5. Premium Increases This Fall Could Inject Health Law Concerns Into Election Campaign

Politico looks at how an expected rise in health premiums coming out shortly before the November election could bring the health law back into the political debate. Also, Morning Consult examines Speaker Paul Ryan's plan for high-risk pools.

Politico: Obamacare's November Surprise
The last thing Democrats want to contend with just a week before the 2016 presidential election is an outcry over double-digit insurance hikes as millions of Americans begin signing up for Obamacare. But that looks increasingly likely as health plans socked by Obamacare losses look to regain their financial footing by raising rates. ... In some ways, the turmoil is not surprising: Under the health law, plans are unable to choose who to insure, or how much to charge them based on their medical history. ... The timing, though, is bad news for Democrats. Proposed rate hikes are just starting to dribble out, setting up a battle over health insurance costs in a tumultuous presidential election year that will decide the fate of Obamacare. (Demko, 5/2)

Morning Consult: Ryan’s Risk Pools Hit On Obamacare Criticism
House Speaker Paul Ryan’s recent proposal to shift sick people to their own health insurance could place a sizable financial burden on the government, but it also gets at a question that Obamacare supporters are contemplating: How to keep the cost of covering sick people from significantly increasing the cost of insurance for the healthy. Ryan’s plan, which he floated to a student audience at Georgetown University last week, would separate people with preexisting conditions from the regularly insured market. His remarks offer a glimpse into one way Republicans would “repeal and replace Obamacare” under a Republican administration. (Owens, 5/2)

Administration News

6. As FDA Turns Watchful Eye On Silicon Valley, Health-Related Tech Companies Adjust Mindset On Agency

Those in the highly competitive industry have begun to think of the Food and Drug Administration as an ally instead of a powerful brake on progress.

The Washington Post: There’s A New Sheriff In Town In Silicon Valley — The FDA
Helmy Eltoukhy’s company is on a roll. The start-up is a leading contender in the crowded field of firms working on “liquid biopsy” tests that aim to be able to tell in a single blood draw whether a person has cancer. Venture investors are backing Guardant Health to the tune of nearly $200 million. Leading medical centers are testing its technology. And earlier this month, it presented promising data on how well its screening tool, which works by scanning for tiny DNA fragments shed by dying tumor cells, worked on an initial group of 10,000 patients with late-stage cancers. Just one thing is holding the company back: Guardant Health has yet to get approval from the Food and Drug Administration. (Cha, 4/28)