Posts Tagged ‘Food and Drug Administration’

First Amendment claims seen as Rx for drug makers, headache for consumers

Saturday, October 14th, 2017

By Paul Raeburn
Off-label promotion has long been considered a serious white-collar crime. The FDA has fined drug companies billions of dollars for off-label violations. The aim: to prevent them from overstating the benefits and understating the risks of their products, a practice known as misbranding – and one that sometimes leads to patients getting drugs that prove harmful or even deadly.
The post First Amendment claims seen as Rx for drug makers, headache for consumers appeared first on Florida Bulldog.

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Scientists urge tighter scrutiny of germ-fighting chemicals

Friday, June 30th, 2017

By Paul Feldman
More than 200 scientists and public health advocates are urging regulators to take a closer look at the potential dangers of antimicrobial chemicals including triclosan, an additive that has been banned from hand soaps but remains an active ingredient in products ranging from building materials to Colgate’s Total toothpaste.
The post Scientists urge tighter scrutiny of germ-fighting chemicals appeared first on Florida Bulldog.

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CDC: Don’t donate sperm in 3 Florida counties due to Zika

Monday, March 13th, 2017

Men from three Florida counties shouldn’t donate sperm because of a small risk of spreading Zika, U.S. health officials said Monday.
The guidance had previously applied to Miami-Dade County, the only place in Florida where there’s evidence mosquitoes spread the virus. But infections were reported in people in South Florida who couldn’t clearly be linked to Miami-Dade.
On Monday, the Centers for Disease Control and Prevention said the advice should extend to two counties north of Miami — Broward and Palm Beach. The recommendation applies to men who lived or traveled in those counties since June 15.
Zika is mainly spread by mosquito bites, but it can also be spread through sex. People can be infected without getting sick, and the virus can remain in semen for months.
There is no evidence of a pregnant woman being infected by Zika through a sperm donation, and such a risk is considered low, CDC officials said. Infection during pregnancy can lead to severe brain-related birth defects.
The Food and Drug Administration regulates sperm donations, and previously advised sperm banks they shouldn’t accept donors if they had been diagnosed with Zika or had been to an area with widespread Zika within the past six months. Sperm banks should consider the CDC’s new advice discouraging donations from men in the three counties, an FDA spokeswoman said.
There are 12 sperm donor banks in the three South Florida counties, CDC officials said. While blood donations can be tested for Zika, there’s not a good test for semen, according to the FDA.
The last case of mosquito transmission of Zika in Florida was in December. But officials think it’s possible the bugs will start spreading it again this summer. Some 221 people got Zika from mosquitoes in the continental U.S. last year, most in the Miami area. There were six cases in Texas.

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Vern Buchanan demands answers on VA drug thefts

Thursday, March 2nd, 2017

Congressman Vern Buchanan Thursday demanded answers from the new Veterans Affairs secretary about the nationwide theft of opioids and prescription drugs intended to help suffering veterans.
In a letter to VA Secretary David Shulkin, the Sarasota Republican wrote, “I’m concerned that Florida veterans may be at risk following press reports of a shocking spike in drug thefts at VA health facilities across the country.”
“The perpetrators are stealing directly from veterans who need help,” Buchanan wrote. “In addition, those VA employees may be using the stolen drugs at work, endangering the veterans they’re supposed to be caring for.”
A former VA employee in Baltimore was sentenced to 39 years in prison for causing a Hepatitis C outbreak after stealing a powerful painkiller intended for patients headed into surgery. After injecting the narcotic into himself, the employee refilled the same needle with saline solution and injected it into veterans. The employee had Hepatitis C and exposed more than 150 veterans to the deadly disease.
The Associated Press reported that drug loss or theft at federal hospitals, 98 percent of which are VA facilities, increased tenfold between 2009 and 2015 nationwide.
The VA’s inspector general has pointed to over 100 open investigations around the country.
The reports of missing prescriptions and opioids at VA hospitals come in the midst of a national crisis – drugs now kill more Americans than car accidents annually.
Charges have also been brought in VA drug theft cases across the country, including in Utah, Arkansas, New York, Rhode Island and California according to The Associated Press.
Buchanan specifically asked that the VA disclose how many facilities in Florida experienced drug theft and loss; which facilities were hit; the type and quantity of missing drugs; what the street value of the missing drugs was; how many Florida VA employees were involved, what had been done to discipline

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Senate panel approves Nikki Haley nomination to U.N.

Tuesday, January 24th, 2017

The Latest on activities in Congress (all times EST):
12:25 p.m.
The Senate Foreign Relations Committee has overwhelmingly approved South Carolina Gov. Nikki Haley‘s nomination to be U.S. ambassador to the United Nations.
By voice vote, the panel recommended President Donald Trump‘s selection of Haley to the full Senate. She is expected to be confirmed easily.
Sen. Ben Cardin of Maryland, the committee’s top Democrat, backed Haley’s nomination. Cardin says what Haley lacks in foreign policy experience, “she makes up for in capability, intelligence, and a track record of building coalitions in South Carolina.”
During her confirmation hearing, Haley declared her support for moving the U.S. Embassy in Israel from Tel Aviv to Jerusalem. The shift may trigger increased violence in the Middle East.
Haley also took a hard line against Russia. She says she doesn’t think Moscow can be trusted right now.
12:20 p.m.
President Donald Trump’s pick for health secretary is adamant that the new administration will protect people with pre-existing medical problems even as it moves to repeal the Obama-era law prohibiting insurance discrimination.
Georgia Rep. Tom Price told the Senate Finance Committee that “we need to make sure nobody loses their insurance or is unable to gain insurance because of pre-existing conditions.” Price was being questioned by Florida Democratic Sen. Bill Nelson.
But the way Republicans would go about guaranteeing coverage could be very different. They are looking at special “high-risk” insurance pools as a last resort for people who can’t get coverage otherwise. That hasn’t worked well in the past, providing costly coverage to a limited number of people.
Price said “nobody ought to be priced out of the market for having a bad diagnosis.”
12:15 p.m.
Health care plan? What health care plan?
Laughter erupted during a tense Senate confirmation hearing when Sen. Sherrod Brown, D-Ohio, asked President Donald Trump’s health nominee if it’s true that the new

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Joe Henderson: Donald Trump ‘saves’ Indiana jobs; Eric Newman asks ‘why not us?’

Friday, December 2nd, 2016

Eric Newman read news reports of the fight by incoming president Donald Trump to keep the Carrier air conditioning company from moving jobs to Mexico and thought, hey, why not us?
Newman owns the J.C. Newman Cigar Company in Tampa and has been fighting the Food and Drug Administration over regulations that Newman says could put his 121-year-old operation out of business.
So when this lifelong Democrat saw what Trump was doing to save jobs in Indiana, he described himself as “cautiously optimistic.”
“If President Trump is true to his word that overregulation is killing small businesses, we are the poster child for that,” Newman said. “It’s still way too early to tell if he can help us, but I feel better about it now.”
At its peak, Tampa was home to about 150 cigar-making companies, but Newman’s is the last such operation in the city. Other companies folded under increased regulatory pressure by the FDA and health concerns about tobacco use.
But, Newman has always argued that cigars are different from cigarettes and shouldn’t be held in the same category as a cancer risk.
“You go outside an office building, and you’ll see people huddled around smoking cigarettes,” he said. “You don’t see them smoking cigars. It’s not the same thing.”
You can’t blame Newman for feeling his government is out to get him, though. In addition to stringent new FDA rules that restrict the development of new product lines, Newman pointed to an executive order by President Obama that benefited Cuban cigar-makers.
The order allows travelers to bring all the Cuban cigars they want into the United States for personal consumption. Those cigars aren’t subject to the same regulations faced by Newman’s company.
“I have no problem competing with Cuban cigars on an equal footing,” Newman said. “But this exemption by President Obama gives such an advantage

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