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Europe Fines Drug Companies for Delaying Generics

June 19, 2013 by Leave a Comment

On Wednesday, the European Commission fined a Danish pharmaceutical company and a number of generic producers a total of 146 million euros, or $195 million.

The commission said that Lundbeck of Denmark colluded with companies like Ranbaxy of India and Merck of Germany in 2002 and 2003 to delay market entry of a less expensive generic version of a blockbuster antidepressant called citalopram. Joaquín Almunia, the European commissioner for competition, said that Lundbeck also destroyed significant quantities of the low-cost version of the drug.

“All this occurred at the expense of patients who were deprived of access to cheaper medicines,” Mr. Almunia said at a news conference on Wednesday. “It also harmed our public health systems, who for a longer period had to artificially bear the costs of an expensive medicine and one of the most widely prescribed antidepressants.” Lundbeck said it had done nothing wrong and would appeal the decision. “The company acted transparently and in good faith in trying to protect our patents,” Lundbeck said in a statement. “Upon entering the agreements, they were all reviewed by external antitrust experts.”

The case mirrors a decision on Monday by the United States Supreme Court, which empowers the Federal Trade Commission to sue drug makers that engage in so-called pay-for-delay tactics. The Supreme Court decision is likely to increase the number of generic drugs, in that way benefiting consumers. The F.T.C. said that pay-for-delay deals cost Americans $3.5 billion a year in higher drug prices.

Many European governments with socialized medical systems buy or help to pay for prescription drugs used by citizens, which means that the blocking of generics affects those nations’ budgets. Mr. Almunia said that when generic versions of citalopram became available in Britain, during the second half of 2004, prices there dropped by 90 percent.

The scale of savings in Britain helped to ensure that “public health systems can remain economically sustainable in these times of difficult budgetary constraints,” Mr. Almunia said. Peter Kaplan, a Federal Trade Commission spokesman, would not comment on the European decision, but he indicated that officials had been coordinating on the issue of drug pricing. “F.T.C. staffers have had productive policy discussions with their counterparts in the E.U. on the pay-for-delay issue, which is a longstanding enforcement priority at the F.T.C.,” Mr. Kaplan said.

Similarly, European Union officials said their decision on Wednesday was not timed to follow the Supreme Court case.

Early this year, the commission accused the drug giants Johnson Johnson and Novartis of colluding to delay the availability of a generic version of fentanyl, a drug often used to ease severe pain. A year ago, the commission accused the French pharmaceutical company Servier and competitors of delaying the generic entry of perindopril, a cardiovascular medicine. And in 2011, the commission opened an investigation into whether the American pharmaceutical company Cephalon and the generic maker Teva of Israel hindered the entry of the generic version of modafinil, used for the treatment of certain types of sleeping disorders.

Those cases still are pending.

In the Lundbeck case, Mr. Almunia’s office said that various generic makers colluded with the Danish company, agreeing to not enter the market in return for “substantial payments and other inducements from Lundbeck amounting to tens of millions of euros.” Commission officials said that they had found documents referring to a “ ‘club’ being formed and ‘a pile of $$$’ to be shared among the participants.”

The European Commission fined Lundbeck 93.8 million euros, which amounts to roughly 4.6 percent of its 2012 sales. The regulator can fine companies as much as 10 percent of annual sales.

Article source: http://www.nytimes.com/2013/06/20/business/global/eu-fines-drug-companies-for-delaying-generics.html?partner=rss&emc=rss

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F.D.A. Approves Raptor Drug for Form of Cystinosis

April 30, 2013 by Leave a Comment

Reluctant to say it aloud, Natalie Stack wrote her 12th birthday wish on a restaurant napkin: “To have my disease go away forever.”

A decade later, her wish is a step closer to being realized.

On Tuesday, the Food and Drug Administration approved a new drug developed with early funding from a foundation that Natalie’s parents established in response to that plea. The drug, which will be sold by the Raptor Pharmaceutical Corporation under the name Procysbi, is for nephropathic cystinosis, an extremely rare inherited disease that, if untreated, typically destroys the kidneys by age 10 and even with a kidney transplant can lead to death by early adulthood.

The story behind Procysbi’s development is yet another example of the important role that determined parents and disease foundations can play in supporting drug development, particularly for rare diseases.

But Procysbi’s approval could also raise troubling questions about whether society can afford to pay extremely high prices being charged for drugs that treat rare diseases. That is because Procysbi is not a new chemical entity, but rather a more convenient and more tolerable version of an existing drug. The existing drug costs about $8,000 a year, whereas Procysbi is expected to cost $100,000 to $300,000.

High prices are typical for drugs to treat so-called orphan diseases. The health care system has tolerated that because, given the small numbers of patients, the overall cost is not that high. But as the orphan drug business model becomes increasingly popular among pharmaceutical companies, the collective cost of the drugs is beginning to mount.

The market research firm EvaluatePharma recently predicted that orphan drugs will constitute 15.9 percent of spending on prescription drugs by 2018, up from 5.1 percent in 1998. And a survey of 50 insurers and pharmacy benefit managers by J.P. Morgan found that drugs for rare diseases would be one of the areas increasingly subject to scrutiny and possible restrictions on use.

While many medicines are unpleasant to take, the existing drug for cystinosis — Cystagon, from Mylan Inc. — literally stinks. It has a strong rotten-egg smell that causes bad breath and body odor. It also causes nausea, vomiting and other abdominal problems. Moreover, it must be taken every six hours, which means patients have to get up in the middle of the night, or their parents must wake them.

Procysbi has the same ingredient as Cystagon but consists of enteric-coated spheres for delayed release. It can be taken every 12 hours instead of every six. The gastrointestinal side effect, halitosis and body odor, are reduced, though not eliminated, according to the parents of children with the disease.

Christopher M. Starr, co-founder and chief executive of Raptor, said he expected it would take time to persuade insurers to bear the extra cost.

“I get it,” he said. “It seems trivial when you first look at this.” He said doubters would think: “You’re dying of a disease. Take it every six hours if that is what you need to do.”

But Dr. Starr argued that the “subtle advantages” of Procysbi “add up to a significant benefit.” He said as many as 80 percent of patients skip doses of Cystagon, which studies have shown can lead to more rapid deterioration of the kidneys, eyes and other organs. The more tolerable Procysbi should allow people to better take their medicines.

Dr. Starr said the price reflected the value of the drug and the need to recoup Raptor’s development costs. The company’s regulatory filings show it has spent $37.4 million on research and development of the cystinosis drug from the company’s inception in 2005 through the end of 2012. Total corporate expenses in that period were $110 million.

Procysbi is the first drug approved for Raptor, which is based in Novato, Calif. Analysts expect sales could exceed $100 million annually. Shares of Raptor rose 10 percent in Tuesday trading.

Procysbi treats a very rare disease. Only about 500 people in the United States, and 3,000 worldwide, are estimated to have cystinosis, according to the F.D.A. The disease is characterized by a buildup in cells of the amino acid cystine. The buildup damages the kidneys and eyes and eventually the thyroid gland, muscles and other organs.

Procysbi works by breaking down cystine. Its active ingredient is cysteamine, the same as in Cystagon. Cysteamine was first shown to work in the 1970s by a team led by Dr. Jerry A. Schneider at the University of California, San Diego. The F.D.A. approved Cystagon in 1994.

The drug research got an added boost from the efforts of the Stacks.

When Natalie Stack was born in 1991, “we were told we’d be lucky if Natalie lived to graduate from high school,” said her mother, Nancy Stack, who lives in Corona del Mar in Southern California. But it was not until reading Natalie’s birthday wish in 2003 that Ms. Stack and her husband, Geoffrey, a real estate developer, formed the Cystinosis Research Foundation, raising almost $400,000 at an initial cocktail party.

Article source: http://www.nytimes.com/2013/05/01/business/fda-approves-raptor-drug-for-form-of-cystinosis.html?partner=rss&emc=rss

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F.D.A. Posts Injury Data for 3 Drinks

November 16, 2012 by Leave a Comment

The Web posting of the records by the agency included 13 previously undisclosed injury filings that mentioned Rockstar Energy. The F.D.A. also released filings related to 5-Hour Energy, a popular energy shot, and Monster Energy, another popular brand.

The agency’s action comes a day after The New York Times reported that the agency had received more than 90 filings about 5-Hour Energy, including reports that cited its possible involvement in 13 fatalities. In late October, the F.D.A. confirmed that it had received five fatality reports that cited Monster Energy.

The filing of an incident report with the F.D.A. does not mean that a product was responsible for a death or an injury or contributed to it in any way. The makers of 5-Hour Energy and Monster Energy have insisted their products are safe and unrelated to the problems reported to the F.D.A.

Officials of Rockstar Energy Drink, which is based in Las Vegas, did not return calls on Thursday seeking comment

The release of the filings may represent a turnabout in agency policy. While units within the F.D.A. that oversee prescription drugs and medical devices make so-called adverse event reports about those products available to the public through Web sites or other means, the unit that oversees dietary supplements routinely does not do so.

Shelly Burgess, an agency spokeswoman, said the agency had decided to release the records “in an effort to be transparent.” She added that the filing of a report did not show a product was at fault.

“If we find a relationship between consumption of the product and harm, F.D.A. will take appropriate action to reduce or eliminate the risk,” Ms. Burgess said.

Meanwhile, two senators, Richard Durbin of Illinois and Richard Blumenthal of Connecticut, sent a letter on Thursday to the F.D.A. commissioner, Dr. Margaret A. Hamburg, seeking a meeting to discuss energy drinks. Mr. Durbin and Mr. Blumenthal are Democrats.

Both lawmakers have pressed the agency to tighten regulations of energy drinks, but it has said that it has not yet seen sufficient evidence to do so.

“There has been alarming evidence that energy drinks pose a potential threat to the public’s health,” the two senators wrote.

Many medical experts say healthy adults can safely consume 400 milligrams or more of caffeine daily, or about as much caffeine as in several 8-ounce cups of coffee or in two 16-ounce cans of many energy drinks.

There is scant data, however, about whether such levels are safe for young teenagers to whom energy drinks are frequently marketed. Along with caffeine, energy drinks typically contain other ingredients like high levels of certain B vitamins and a substance called taurine, which exists inside the body.

The records released on Thursday by the F.D.A. cover a period from 2004 to last month. But the vast majority of filings are from the last four years; beginning in late 2008, makers of dietary supplements were required to notify the F.D.A. of a report of a fatality or injury that might have been associated with their products.

The three products involved in the release — Rockstar Energy, 5-Hour Energy and Monster Energy — are all marketed as dietary supplements. Other energy drinks like Red Bull, NOS and AMP are marketed by their producers as beverages. There is not a mandatory reporting requirement for beverages, though makers can do so voluntarily.

In releasing the filings, the F.D.A. said it thought that even with the mandatory reporting requirement for dietary supplements, “only a small fraction of adverse events associated with any product is reported.”

Last year, the F.D.A. received about 2,000 such reports about dietary supplements and weight-loss products, two broad categories that include more than 50,000 products.

Officials of the F.D.A. dietary supplement unit have said they were working on ways to make reports of adverse events public, but they have not set a timetable to do so. The records related to Monster Energy and 5-hour Energy came to light because they were released by the F.D.A. under the Freedom of Information Act.

Over all, sales of energy drinks in the United States grew an estimated 16 percent last year to $8.9 billion, a record level, according to Beverage Digest, a trade publication.

A report last year by the federal Substance Abuse and Mental Health Services Administration found that the annual number of emergency room visits in this country linked to energy drinks rose to more than 12,000 in 2009, the latest year for which data was available. The figure represents a tenfold jump from the number of such visits reported in 2005.

Article source: http://www.nytimes.com/2012/11/16/business/scrutiny-of-energy-drinks-grows.html?partner=rss&emc=rss

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Bits Blog: Google Reaches Settlement on Illegal Ads

August 24, 2011 by Leave a Comment

12:48 p.m. | Updated to include official announcement.

The government announced Wednesday that Google will pay $500 million to settle government charges that it has shown illegal ads for online Canadian pharmacies in the United States.

The fine, which the Justice Department said is one of the largest such penalties ever, covers revenue that Google earned from the illegal advertisers and revenue that the Canadian pharmacies received from United States customers.

As part of the settlement, Google acknowledged that it improperly aided the Canadian pharmacies — which operate illegally by failing to require a prescription or selling counterfeit drugs — in advertising through its AdWords program.

Since 2010, after Google became aware of the investigation, it has required that all Canadian online pharmacy advertisers be certified by the Canadian International Pharmacy Association and has specified that they can advertise only to Canadian customers. United States pharmacy advertisers must be certified by the National Association of Boards of Pharmacy.

The investigation was first revealed in May, when Google said in a government filing that it set aside $500 million for the potential settlement of a Department of Justice investigation into its advertising practices. The move decreased its quarterly profit by 22 percent.

Google has said in the past that regulating these pharmacies on its site is a cat-and-mouse game, because when it introduces rules to prevent them from advertising, they find new ways to appear on Google.

Web sites are liable for ads on their sites from advertisers that break federal criminal law.

“We banned the advertising of prescription drugs in the U.S. by Canadian pharmacies some time ago,” Google said in a statement Wednesday. “However, it’s obvious with hindsight that we shouldn’t have allowed these ads on Google in the first place. Given the extensive coverage this settlement has already received, we won’t be commenting further.”

In a statement issued by the Justice Department, James M. Cole, a deputy attorney general, said: “The Department of Justice will continue to hold accountable companies who in their bid for profits violate federal law and put at risk the health and safety of American consumers. This settlement ensures that Google will reform its improper advertising practices with regard to these pharmacies.”

The investigation was led by officials from the United States attorney’s office for the District of Rhode Island and the Food and Drug Administration’s Office of Criminal Investigations.

Article source: http://feeds.nytimes.com/click.phdo?i=b37ac02753711bf603a388b8c4b483c5

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The Health Consumer: For Those With Diabetes, Older Drugs Are Often Best

May 28, 2011 by Leave a Comment

WHEN it comes to prescription drugs, newer is not necessarily better. And that’s especially true when treating diabetes.

One in 10 Americans has Type 2 diabetes. If the trend continues, one in three will suffer from the disease by the year 2050, according to the federal Centers for Disease Control and Prevention.

Most Type 2 diabetes patients take one or more drugs to control blood sugar. They spent an estimated $12.5 billion on medication in 2007, twice the amount spent in 2001, according to a study by the University of Chicago. (That figure does not including drugs that diabetics are often prescribed for related health conditions, like high blood pressure and high cholesterol.)

Why the increase? More diagnosed patients, more drugs per patient and an onslaught of expensive new drugs, according to Dr. G. Caleb Alexander, assistant professor of medicine at the University of Chicago and lead author of the study. Since 1995, several new classes of diabetes medications have come on the market. Diabetes drugs are important to the pharmaceutical industry, more lucrative than drugs for many other chronic diseases, Dr. Alexander noted in an interview.

Simply put, many of these drugs help the body produce less glucose or more insulin, the hormone that shuttles glucose into cells for use as energy, or they increase the body’s sensitivity to its own insulin.

Patients and health care professionals have long hoped that as pharmaceutical companies found ways to help the body lower blood sugar, they would produce safer and more efficient alternatives to older medications. But a true breakthrough doesn’t seem to have happened yet.

A report released in March by the federal Agency for Healthcare Research and Quality and conducted by researchers at Johns Hopkins University reviewed data from 166 studies to evaluate the effectiveness and risks of various diabetes medicines. The researchers concluded that drugs that have been around for years are more effective at lowering blood sugar and often work with fewer side effects than the newest drugs. And because so many older drugs now are available as generics, they often cost just a fraction of the price of newer brand-name drugs.

Low-cost treatment is imperative to turning back the diabetes epidemic, said Dr. Wendy L. Bennett, assistant professor of medicine at Johns Hopkins University School of Medicine and the lead author of the A.H.R.Q. study. Experts estimate that only 25 percent of diabetic patients are getting the treatment they need, and expense is a big reason. Even well-insured patients may reel when confronted with the $6,000 a year it takes on average to manage the disease (not counting the costs of such complications as heart disease, stroke, and liver and kidney damage).

Becoming educated is the most important thing a person with diabetes can do to help stem the cost of medications as well as avoid complications, said Dr. Bennett. Here, three crucial things you should know.

Step 1: Fight diabetes with lifestyle changes.

Cost: Free or low cost.

If you are pre-diabetic or recently diagnosed, you may be able to dodge the expense of drug treatment with exercise and a better diet and by quitting smoking. None of this has to cost a fortune, and in any event healthier foods and, if necessary, a gym membership or other exercise program are well worth the investment. Even if you are taking medication, these lifestyle changes can help the medicine work better and longer.

For more information go to www.cdc.gov/diabetes and the Web site for the American Diabetes Association, www.diabetes.org.

Step 2: If you need to begin taking a drug to control blood sugar, start with metformin, the most common and one of the least expensive diabetes drugs.

Cost: $36 for 100 pills (500 milligrams); usually taken twice a day. Prices may be even lower at Wal-Mart, Target and other discount pharmacies.

Metformin almost always works as a first-line drug, except for patients suffering from severe kidney disease, said Dr. Bennett. What’s more, metformin generally does not cause hypoglycemia, a common and dangerous side affect of many diabetes drugs.

It also does not seem to cause weight gain, as some other diabetes drugs do, said Dr. Bennett. “The last thing you want if you’ve been diagnosed with diabetes is additional weight,” she added.

A study published in Consumer Reports Health in February 2009 also found that older, less expensive diabetes drugs were just as effective as the new ones. Better yet, they have established safety records, while some newer diabetes drugs have been found to increase cardiovascular and other health risks.

“The expensive drugs are third- and fourth-line drugs,” said Dr. Marvin Lipman, chief medical adviser for Consumer Reports Health and a practicing endocrinologist in Westchester County, N.Y. “If you don’t get results with the less expensive drugs, you go to those. But you shouldn’t start there.”

Avoid: Certain newer diabetes drugs have been associated with heart failure and other risks.

Avandia, for example, has been linked to an increased risk of heart attacks. In September 2010, after years of debate, the Food and Drug Administration severely restricted Avandia’s availability, allowing it to be prescribed only to patients in a special program who had not responded to other drugs and were taking the medicine under a doctor’s strict supervision. This month the agency expanded those restrictions to include related drugs Avandamet and Avandaryl, which also contain rosiglitazone, the active agent in Avandia.

Step 3: Choose combination drugs from among inexpensive generics.

Cost: Glimepiride, $13 for 100 pills (1 milligram). Glipizide, $64 for 100 pills (5 milligrams).

Most diabetics will have to eventually take more than one drug to keep blood sugar under control. The good news here from the Johns Hopkins study is that inexpensive metformin is also quite effective in combination with other generics, such as glimepiride and glipizide.

“Most combinations worked equally well, so when you’re adding a drug, you could choose a generic to save costs,” said Dr. Bennett. She added, however, that some drugs used with metformin might increase the risk of side effects such as hypoglycemia or weight gain. Patients should discuss each drug’s pros and cons, as well as cost, with their doctors.

Avoid: Do not start with one of the more expensive drugs in combination with metformin. In some cases, patients ultimately may need a combination of both generics and the newer drugs, but this usually becomes appropriate only after a less expensive combination has been used for some time or if the patient isn’t responding to the less expensive combination, said Dr. Bennett.

Article source: http://feeds.nytimes.com/click.phdo?i=1c055a54cd9e44402b35c8891b09d5da

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