Category Archives: Business Law

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FDA Wants To Stop Pharma From ‘Gaming’ Generic Drug System

The U.S. Food and Drug Administration moved on Wednesday to prevent pharmaceutical companies from “gaming” the system to block or delay entry of generic rivals.

FDA Commissioner Scott Gottlieb said in a blog post that the agency plans to hold a public meeting on July 18 to identify ways pharmaceutical companies are using FDA rules to place obstacles in the way of generic competition.

“We know that sometimes our regulatory rules might be ‘gamed’ in ways that may delay generic drug approvals beyond the time frame the law intended, in order to reduce competition,” he said in the blog post. “We are actively looking at ways our rules are being used and, in some cases, misused.”

The move comes as President Donald Trump and lawmakers in Congress search for ways to lower the cost of prescription drugs. Trump is preparing to put out an executive order on drug pricing, according to media reports, and last week U.S. Senator Ron Wyden introduced a bill to require companies to explain the reasons for significant price increases.

Full Read – http://www.nbcnews.com/health/health-news/fda-wants-stop-pharma-gaming-generic-drug-system-n775151

Celebrity developer pleads no contest to Bel-Air mega-mansion charges. But what happens to the 30,000-square-foot estate?

Three years ago, Los Angeles city officials demanded that builders halt work on a colossal mansion in the rarefied hills of Bel-Air.

The massive home being erected on Strada Vecchia Road was bigger and taller than allowed, city prosecutors said. It also included entire areas — bedrooms, decks and a vast IMAX theater — that the city says were never approved.

Neighbors said they feared for their safety, complaining that the hillside above their homes had been dangerously destabilized.

City officials yanked the building permits. Luxury developer Mohamed Hadid was slapped with criminal charges. The case drew international attention with its cocktail of criminal accusations, real estate excess and star power in Hadid, who has appeared on “The Real Housewives of Beverly Hills” and whose daughters Gigi and Bella have graced magazine covers.

After more than a year of legal wrangling, Hadid pleaded no contest to the misdemeanor charges Tuesday. But neighbors remain anxious about what will ultimately happen to the roughly 30,000-square-foot mega-mansion uphill.

“You still have this horrendous thing hanging over the hillside,” said Joseph Horacek, an entertainment lawyer who repeatedly lodged complaints as the home was under construction, in an April interview at his home. He has nicknamed the unfinished building, which towers over his winding street below, the “Starship Enterprise.”

The question goes to the heart of how L.A. should hold real estate developers accountable. Hadid, who did not appear in court Tuesday, is scheduled for a sentencing hearing next month. City prosecutors want the judge to impose more than a dozen requirements, including hundreds of hours of community service, fines of $1,000 for each of the three charges, and a $250,000 contribution to a community improvement fund.

Read Full – http://www.latimes.com/local/lanow/la-me-ln-bel-air-building-20170530-htmlstory.html

Ja Rule on Fyre Festival Being Under FBI Investigation

BY TRACE WILLIAM COWEN

As expected, the Fyre Festival woes continue. A criminal investigation into the Fyre proceedings is reportedly being conducted by the Federal Bureau of Investigation and the United States attorney’s office for the Southern District of New York, the New York Times reported Sunday. Federal authorities, according to a Times source, are looking into “possible” mail, wire, and securities fraud.

The Times report also adds greater context to the botched Great Exuma fest’s wide range of victims. Blink-182, who pulled out of their headlining Fyre slot in the nick of time “after much careful and difficult consideration,” still have tour equipment stuck in customs limbo. Festival employees are awaiting payment. One restaurant owner, who catered meals, told the Times she’s still waiting on her $134,000.

How celebrities’ ‘golden glow’ shines on public health

Updated 12:20 PM ET, Thu May 18, 2017

(CNN)When celebrities speak, it seems, the world listens — even when it comes to personal and public health.

Just look at what happened after Charlie Sheen’s HIV disclosure two years ago, said John Ayers, a research professor at San Diego State University.

 

Sales of in-home HIV testing kits reached record highs around the same time the actor announced that he had been diagnosed as HIV-positive in 2015, according to a study published in the journal Prevention Science on Thursday. Ayers was a co-author of the study.

 

About the same time, “in record numbers, people were going online, seeking out information on what the signs of HIV are, on how to find and appropriately prevent HIV with devices such as condoms and also how to get tested,'” Ayers said. “We’ve seen this … many times over.”

 

For the new study, Ayers and his co-authors monitored weekly sales of OraQuick, the only FDA-approved at-home oral HIV testing kit available in the United States, from 2014 to 2016.

 

The researchers found that there were 8,225 more sales than they expected the week of Sheen’s HIV status announcement. Elevated sales continued for four weeks after Sheen’s disclosure.
The findings show a correlation, not a direct causation. Yet in a previous study, Ayers and his colleagues also found that Google searches for HIV testing and related topics also spiked after Sheen’s announcement.

 

“The most common reaction is, ‘So what? What does a search really mean?’ Our new study shows not only did Sheen’s disclosure lead people to seek information about HIV prevention, it also corresponded with record levels of at-home rapid HIV testing sales,” Ayers said.

hey are not doctors, many celebrities have had both positive and negative ties to public health in recent years.

 

Luxury Italian shoe firm Gianvito Rossi accused of refusing to give Serena Williams a celebrity discount because ‘the company did not want African American women to wear its shoes’

 

  • Gianvito Rossi managers have been  accused of racism in a new lawsuit
  • Allegedly refused to give tennis star Serena Williams a celebrity discount because ‘the company did not want African American women to wear its shoes’
  • They also used ‘racially disparaging comments about Ms. Williams’, suit claims
  • Whitney Wilburn, who is black, also claims her ex-manager Grace Mazzilli was ‘hostile to Wilburn based upon her race and age’
  • She was later fired without warning, replaced with a younger, white employee

Bosses at luxury shoe company Gianvito Rossi have been accused of branding Serena Williams ‘disgusting’ and refusing to give her a celebrity discount because she’s black.

Whitney Wilburn, who went to work for the shoe firm’s Manhattan boutique in 2015, has filed a racial discrimination lawsuit against her former employer.

Wilburn claims her old boss Grace Mazzilli had a ‘racial animosity toward African Americans’, New York Post.

Read more: http://www.dailymail.co.uk/news/article-4520376/Shoe-company-accused-racism-against-Serena-Williams.html#ixzz4hg7djlNt
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