oxycontin

F.D.A. Bars Generic OxyContin

The move represents a victory for OxyContin’s manufacturer, Purdue Pharma, which in 2010 introduced a formulation of the drug that was less prone to tampering.

The original version of OxyContin, which was approved in late 1995, could be easily crushed, a step that released its entire narcotic payload at once rather than over time as intended. The new version turns into a jellylike mass when crushed.

Some state attorneys general and pain treatment experts had also urged the F.D.A. to block the release of generic versions of OxyContin, arguing that failing to do so would feed street demand for strong narcotics. But the decision is also likely to result in higher prices for OxyContin, a time-release form of a narcotic called oxycodone, because it will not face generic competition.

The decision by the F.D.A. came on the day when the patent for the original version of OxyContin was set to expire. That would have allowed generic producers to introduce their own version of the formulation. F.D.A. officials said that several producers had applications to sell a generic form of OxyContin pending before the agency.

As part of Tuesday’s decision, the F.D.A. also said it had approved a label for the new version of OxyContin stating that it was less prone to abuse through inhaling or injecting it.

The decision is the first time that the agency has allowed a manufacturer to state that a narcotic drug has tamper-resistant properties, said an agency official, Dr. Douglas C. Throckmorton.

Dr. Throckmorton said the F.D.A. had looked at data from several studies, some of it underwritten by Purdue Pharma, in arriving at its decision. He said that while the data was not perfect, the agency had concluded that it was enough to show that the new version of OxyContin was safer, in its abuse resistance, than the original version.

As a result, the efficacy of that original version — and by extension the efficacy of any generic version of it — no longer outweighed its risks, since the therapeutic value of older and new versions of the drug were the same, he added.

“We recognize that we are looking at new territory,” Dr. Throckmorton said, referring to the standards under which it would allow claims for abuse resistance.

The decision by the F.D.A. comes at a time when the efficacy of strong narcotics like OxyContin for the treatment of long-term pain has come under increasing scrutiny. Citing poor outcomes, some insurers are also seeking to limit how doctors use the drugs.

Along with Purdue Pharma, the manufacturer of another long-acting narcotic painkiller, Endo Pharmaceuticals, has also petitioned the F.D.A. seeking a similar claim of abuse resistance for a newer version of one of its drugs, Opana. If that claim proves successful, generic versions of the original form of Opana would also be barred.

Over the last year, Purdue Pharma and Endo have pushed for federal legislation that would require many opioids to be tamper-resistant, and lobbied in favor of similar state laws.

In Canada, an effort last year by some doctors and local officials to deter sales of generic versions of OxyContin there fell flat. While companies like Purdue Pharma insist the public’s health is their main concern, others note that producers introduced tamper-resistant versions of their products just as the drugs were about to lose patent protection.

In court papers filed in response to a lawsuit filed by Endo, the F.D.A. described the company’s action as a “thinly veiled attempt to maintain its market share and block generic competition.”

At time of introduction in late 2010, the price of the new version of OxyContin was about $6 per 40 milligram tablet, the same then as the price that was not tamper resistant. Since then, the price of the new version has risen to about $6.80 for a tablet of that strength. Opana costs about the same amount for a pill of the same painkilling strength.

When the F.D.A. approved the original formulation of OxyContin in 1995, the agency allowed its maker to claim that the drug’s time-release formulation was “believed to reduce” its potential to be abused. That contention proved disastrously wrong.

Article source: http://www.nytimes.com/2013/04/17/business/fda-bars-generic-oxycontin.html?partner=rss&emc=rss

Social Media History Becomes a New Job Hurdle

A year-old start-up, Social Intelligence, scrapes the Internet for everything prospective employees may have said or done online in the past seven years.

Then it assembles a dossier with examples of professional honors and charitable work, along with negative information that meets specific criteria: online evidence of racist remarks; references to drugs; sexually explicit photos, text messages or videos; flagrant displays of weapons or bombs and clearly identifiable violent activity.

“We are not detectives,” said Max Drucker, chief executive of the company, which is based in Santa Barbara, Calif. “All we assemble is what is publicly available on the Internet today.”

The Federal Trade Commission, after initially raising concerns last fall about Social Intelligence’s business, determined the company is in compliance with the Fair Credit Reporting Act, but the service still alarms privacy advocates who say that it invites employers to look at information that may not be relevant to job performance.

And what relevant unflattering information has led to job offers being withdrawn or not made? Mr. Drucker said that one prospective employee was found using Craigslist to look for OxyContin. A woman posing naked in photos she put up on an image-sharing site didn’t get the job offer she was seeking at a hospital.

Other background reports have turned up examples of people making anti-Semitic comments and racist remarks, he said. Then there was the job applicant who belonged to a Facebook group, “This Is America. I Shouldn’t Have to Press 1 for English.” This raises a question. “Does that mean you don’t like people who don’t speak English?” asked Mr. Drucker rhetorically.

Mr. Drucker said his goal was to conduct pre-employment screenings that would help companies meet their obligation to conduct fair and consistent hiring practices while protecting the privacy of job candidates.

For example, he said the reports remove references to a person’s religion, race, marital status, sexual orientation, disability and other information protected under federal employment laws, which companies are not supposed to ask about during interviews. Also, job candidates must first consent to the background check, and they are notified of any adverse information found.

He argues the search reduces the risk that employers may confuse the job candidate with someone else or expose the company to information that is not legally allowable or relevant. “Googling someone is ridiculously unfair,” he said. “An employer could discriminate against someone inadvertently. Or worse, they are exposing themselves to all kinds of allegations about discrimination.”

Marc S. Rotenberg, president of the Electronic Privacy Information Center, based in Washington, said that employers were entitled to gather information to make a determination about job-related expertise, but he expressed concern that “employers should not be judging what people in their private lives do away from the workplace.”

Less than a third of the data surfaced by Mr. Drucker’s firm comes from such major social platforms as Facebook, Twitter and MySpace. He said much of the negative information about job candidates comes from deep Web searches that find comments on blogs and posts on smaller social sites, like Tumblr, the blogging site, as well as Yahoo user groups, e-commerce sites, bulletin boards and even Craigslist.

Then there are the photos and videos that people post — or find themselves tagged in — on Facebook and YouTube and other sharing sites like Flickr, Picasa, Yfrog and Photobucket.

And it is photos and videos that seem to get most people in trouble. “Sexually explicit photos and videos are beyond comprehension,” Mr. Drucker said. “We also see flagrant displays of weapons. And we see a lot of illegal activity. Lots and lots of pictures of drug use.”

He recalled one man who had 15 pages of photos showing himself with various guns, including an assault rifle. Another man included pictures of himself standing in a greenhouse with large marijuana plants.

Article source: http://feeds.nytimes.com/click.phdo?i=a4febcf5e8a2f36026f519ba08b8f779

F.D.A. Bars Generic OxyContin

Social Media History Becomes a New Job Hurdle

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