OVERNIGHT HEALTHCARE: NIH drug lab shut down

The National Institutes of Health (NIH) was ordered to halt drug-making operations on Thursday after a federal investigation of a fungal contamination that potentially impacted 46 clinical studies.   

So far, six patients may have been exposed to the contaminated drug and all are being monitored for symptoms. In all, 250 people are scheduled to participate in the studies, though the “vast majority” are not due for immediate treatment, the NIH said.

“This is a distressing and unacceptable situation,” Dr. Francis Collins, director of the NIH, wrote in a release on Thursday, adding that the risk to patients is “deeply troubling.”

{mosads}The shutdown is the result of a weeks-long investigation by the Food and Drug Administration (FDA), which identified major “operational failures” ranging from inadequate quality control to insufficient employee training.

FDA inspectors pinpointed more than a dozen problems with the upkeep and practices of the NIH pharmacy. In a 14-page report, the FDA warned that the NIH’s facilities are “not designed and controlled to prevent contamination risks to sterile drugs.”

In one instance, inspectors saw an NIH staffer with exposed facial hair and skin on his wrists while he handled sterile drugs.

Another inspector found insects in several ceiling lights, as well as a lack of airflow throughout the building, and determined that NIH’s facilities were not maintained in “clean and sanitary” conditions. Read more here.

CRUZ SLAMS ‘EMPTY TABLE’: Sen. Ted Cruz (R-Texas) slammed the Obama administration on Thursday for refusing to send witnesses to a hearing he held about a healthcare dispute now before the Supreme Court.

Cruz had invited Treasury Department officials to testify on the rule-making process, but the administration declined to send them, citing the pending legal challenge.

“I want to take a few minutes to discuss the empty table before us,” Cruz said to open the hearing. “It is a symbol for what little regard the Obama administration seems to have for the American people.”

As he also did in a May 27 letter to the Treasury Department, Cruz raised the possibility of subpoenas. Read more here.

GOP OBAMACARE PLAN IGNORES COURT CASE:  A group of House conservatives on Thursday revealed the latest version of their ObamaCare alternative plan – leaving out how they plan to respond to the looming Supreme Court case on the healthcare law.

But it’s not because they’re at ease with how House leaders are handling the preparation.

“We have multiple people working on multiple plans, so it’s been hard. We’re trying to find out who’s trying to do what,” said Republican Study Committee Chairman Bill Flores (R-Texas). “I hope we have something before King v. Burwell, but frankly we’re running out of time.” Read more here. 

DELAWARE ALSO LOOKS TO SET UP STATE EXCHANGE: Delaware’s top health official said the state is planning to run its own exchange to protect people from losing their subsidies if the Supreme Court rules against ObamaCare.

With a Democratic governor and legislature, Delaware’s plan would be likely to go into effect – if it can gain approval from the Obama administration.

Federal health officials have remained silent about how they will evaluate the states’ blueprints for their own exchanges. Read more here.

Friday’s schedule

The Alliance for Health Reform hosts a congressional briefing on the King v. Burwell case.

State by state

In Vermont, frustrations mount over Affordable Care Act

The shocking stories that led Louisiana to ban charging rape victims hefty medical fees

Assisted-death bill approved by California Senate

What we’re reading

More people going to clinics since ObamaCare started

Ex-Bush official thinks White House could largely fix SCOTUS-ObamaCare mess

FDA backs a drug to increase female sex drive  

What you might have missed from The Hill

Health chief: Premium hikes will be lowered

Lawmakers: ObamaCare calorie rules won’t prevent obesity

GOP open to extending ObamaCare subsidies 

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