Tuesday, January 01, 2013

Drug Makers Losing a Bid to Foil Generic Painkillers - NYTimes.com

Public officials have long urged makers of powerful painkillers to do more to make the medications harder to crush and abuse. But now that some companies have done so, they want something in return — a ban on generic versions of the drugs they make that do not have such tamper-resistant designs. 

In coming months, generic drug producers are expected to introduce cheaper versions of OxyContin and Opana, two long-acting narcotic painkillers, or opioids, that are widely abused.

But in hopes of delaying the move to generics, the makers of the brand name drugs, Purdue Pharma and Endo Pharmaceuticals, have introduced versions that are more resistant to crushing or melting, techniques abusers use to release the pills' narcotic payloads.

The two drug makers, which say they are motivated not by profit but by public safety, have also been waging a multifront political and legal war to block sales of generics that are not tamper-resistant.

The companies argue that the older designs will feed street demand for strong painkillers, drugs that are involved in more than 15,000 overdose-related deaths a year. While some experts say the new tamper-resistant products are not a cure-all for the abuse problem, others say they represent an important step forward.

"I think it would be a shame if the government would allow generics to come in without any tamper-resistant properties," said Dr. Lynn R. Webster, a specialist in Salt Lake City who has consulted with companies developing such safeguards. Over the last year, Purdue Pharma and Endo have backed legislation in Congress that would require many opioids to be tamper-resistant, and lobbied in favor of similar state laws.

They have also urged the Food and Drug Administration to give their tamper-resistant designs a stamp of safety approval that other manufacturers would have to match. The agency does not currently differentiate between drugs that have abuse-resistant qualities and those that do not.

Thus far, the companies' efforts have failed. In mid-December, a federal judge threw out a lawsuit by Endo that would have blocked the F.D.A. from allowing generic versions of its drug, Opana, to go on sale in January. A recent effort by some doctors and local officials in Canada 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 Endo's lawsuit, the F.D.A. described the company's action as a "thinly veiled attempt to maintain its market share and block generic competition."

An F.D.A. official, Dr. Douglas C. Throckmorton, said the agency expected to issue guidance this month that would lay out the types of scientific data that drug producers would have to submit to support a claim that an opioid's design or formulation helped to deter its abuse.

Companies are developing a variety of methods to do that. The new OxyContin pill turns into a gummy mass when an abuser crushes it, and the Opana pill is designed to break into large pieces when manipulated. Other methods include pills that contain a second drug reversing the opioid's narcotic effects if taken inappropriately.

"We understand the value in developing appropriate abuse-resistant technology and we want to find a way of incentivizing that," said Dr. Throckmorton, the F.D.A.'s deputy director for regulatory programs. "But we also understand the value of generics for patients."

A study published in 2012 in a medical journal, The Journal of Pain, found that the percentage of people treated at drug-abuse clinics who reported abusing OxyContin fell significantly since the introduction of the tamper-resistant version.

Some of those abusers said they had switched to other long-acting opioids that were easier to abuse like Opana — before its reformulation — or to illicit drugs like heroin, according to the study, which was financed by Purdue Pharma.

But the generic versions of OxyContin and Opana are expected to be significantly cheaper than the tamper-resistant versions of those drugs. 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 that strength tablet. Opana costs about the same amount for a pill of the same pain-killing strength.

For now, Purdue Pharma and Endo have not indicated that they plan to cut their prices to compete with the generics, meaning government, insurers and patients will pick up the extra costs. The price of generic versions of brand-name drugs typically falls quickly soon after a medicine loses its patent protection. "I think it is great that the industry is creating innovative strategies," said Dr. Daniel P. Alford, a professor at the Boston University School of Medicine. "But these drugs are expensive." Dr. Alford added that it was also unclear just how much the new tamper-resistant designs would reduce abuse, and he expressed concern that the labeling of any potentially dangerous drug as being safer could lead to problems.

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, and experts like Dr. Alford said the F.D.A. needed to be cautious about permitting similar claims.

Along with its lawsuit against the F.D.A., Endo has also been lobbying legislators in several states to introduce bills that would ban pharmacists from dispensing generic painkillers that are not tamper-resistant when a tamper-resistant version has been prescribed.

Most of the bills have not succeeded, in part because pharmacists and others opposed them, saying the measures would keep cheaper generics out of the hands of patients who need them.

Endo did succeed in getting a bill passed this year in Tennessee, but it only requires the state pharmacy board to compile a list of tamper-resistant drugs.

"There was a lot of pushback," said Glen Casada, a Tennessee state representative who helped sponsor a more restrictive bill that did not pass. "A lot of the pharmacists thought it was too much, too soon, too quick."