How Medicare Beneficiaries Can Save Money on Prescription Drugs

Senior Health

How Medicare Beneficiaries Can Save Money on Prescription Drugs

• By Kimberly Leonard, U.S. News and World Report

 

Tips on finding the best Medicare drug plan—and getting the most from it.

Medication costs can make up a large part of seniors citizens' budgets, but a few simple steps can easily save hundreds of dollars a year. The biggest single cost-saver? Picking the right Medicare plan. Whether you're preparing to renew your Medicare enrollment or signing up for Medicare for the first time, you'll want to make a careful selection so you don't end up spending more than you need to. Asking your doctors a few key questions – such as, "Is there a generic?" – can save you a bundle.

First, focus on choosing the right drug plan, which depends in part on which drugs you take. The majority of seniors are enrolled under original Medicare, which includes hospital insurance (known as Medicare Part A) and medical insurance (Medicare Part B).

Getting drug coverage requires one of two additional extra steps. Seniors can either get drug benefits via a private plan regulated by the government, under what's called Medicare Part D, or they can get drug coverage bundled with a private Medicare Advantage plan. For a Part D plan, members pay between $15 and $165.40 a month in premiums for 2013, depending on plans and regions, according to the nonprofit Kaiser Family Foundation.

The alternative is a Medicare Advantage plan, also called Medicare Part C, which replaces original Medicare and often provides prescription drug coverage as well. It is essentially a way to get Medicare A, B and D all lumped into one. Medicare beneficiaries can enroll in Medicare Advantage to receive their benefits in a private health plan, like a health maintenance organization. Across all Medicare Advantage plans with drug coverage, the average premium is $49 per month, according to the Kaiser Family Foundation. Consumers should evaluate on an individual basis whether this is the best option. Depending on your prescriptions and other health care needs, Medicare Advantage may or may not be better for you than original Medicare.

Comparing drug plans or Medicare Advantage plans can feel overwhelming. There are several free, simple tools online that can help you wade through the options. One tool, PlanPrescriber.com, could save users an average of $654 a year by helping them find the right health plan, according to a study the company conducted during the 2012 Medicare enrollment period. The study analyzed 12,000 users who entered their then-current drug plan and at least one prescription they were taking. The average savings were calculated by subtracting the customer's total estimated out-of-pocket spending on their then-current plan from their estimated spending on the plan recommended by PlanPrescriber. (Disclosure: U.S. News has a revenue-generating agreement with eHealthInsurance, which owns PlanPrescriber.)

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Another tool is available through the federal government at Medicare.gov, which, like PlanPrescriber, allows users to compare up to three plans at a time. The main difference: PlanPrescriber CEO Ross Blair says using his site's tool takes seniors an average of three to four minutes versus about 15 minutes on Medicare.gov. Users can also talk to agents over the phone.

ExtendHealth.com is another option, especially for people who may be uncomfortable submitting their information online. Though the tool also allows you to do a Web search and compare up to five plans at a time, the company has 1,200 advisers during enrollment season who can help you over the phone, says Bryce Williams, the company's CEO.

These three websites will also allow you to see drug pricing by pharmacy based on your location. Note that each pharmacy can charge a different amount.

Regardless of which Medicare plan you settle on, keep these other money-saving tips in mind.

Have Drugs Delivered

For medications you take regularly for a chronic condition, opt for the convenience and potential cost-savings of mail-order. In addition to sparing you unnecessary trips to the pharmacy, mail-ordering can sometimes include a 90-day supply at a reduced cost, depending on your insurance company and what kind of medications you need. Once you enroll in an insurance plan you should be able to go to that insurer's website to get your prescriptions delivered, or you can do it over the phone. Be sure to ask your doctor whether he or she needs to sign off on a 90-day supply. And take care to order refills before you need them so there isn't a gap of time when you don't have any pills. Also beware of illegal pharmacies on the Internet, which can pose a serious danger by sending you fake or incorrect prescriptions. Legitimate pharmacies will ask for a faxed prescription from a licensed doctor and a detailed medical history. They will also clearly state their payment, privacy and shipping fees, according to FBI warnings.

Go Generic

Ask your doctor if this is an option. The brand-name version of the drug you take is significantly more expensive than the generic form, if one is available. For example, simvastatin is the generic version of the drug Zocor, which is prescribed to control elevated cholesterol.

Thirty 40 mg tablets of the brand version of the drug will cost between $88.90 and $113.20 a month, according to a search in the Washington, D.C., area on PlanPrescriber, while the generic equivalent can cost as low as $15 a month. The online Medicare tools described above will allow you to compare the generic and brand-name drugs.

Double the Dosage, and Split the Pill

Sometimes pills that are double the dose of your medication cost the same as a single dose, and can easily be cut in half. For instance, if your doctor says you need a 10-mg dose of a particular drug each day, ask him or her whether your medication comes in doses of 20 mg and if they can safely be split in half. Many drugs used to treat high blood pressure and depression can be split, as can all cholesterol-lowering drugs known as statins, according to Consumer Reports. 

Enroll on Time

The open enrollment period for Medicare is from Oct. 15 to Dec. 7, with changes taking effect Jan. 1. You can enroll for the first time when you turn 65, and there are also special enrollment periods when you move or become eligible for Medicaid. 

Though Medicare drug coverage is considered voluntary, you must be getting drug coverage from another source that is at least as good as the offerings through the federal government. If you do not, you can face a penalty fee that grows each month you delay enrollment. Beware: If you are receiving another form of drug coverage, you may actually end up spending more if you sign up with Medicare. This applies to members of the Federal Employee Health Benefits Program, TRICARE (military health benefits) and Veterans Affairs. If you are an active worker on an employer plan, you will want to talk to your human resources department to make sure you understand all your options.

Some Prescription Drug Finding Tools

Medicare.gov

The federal government's site, Medicare.gov, helps users sift through different health plans and compare them three at a time, side by side.

The tool will allow you to do a general search by entering your ZIP code information, or farther down on the page you have the option to do a more specialized search. A questionnaire will ask how you pay for Medicare, then prompt you to enter your prescriptions. You have the option of entering the full name of your drugs, or selecting the first letter to scan a list of drug names.

Once you've entered all your prescriptions, you can indicate the pharmacy you want to use and continue to your plan results.

Phone numbers to call about enrolling in the plans will be provided, though some companies will also give you the option to enroll online.

PlanPrescriber.com

PlanPrescriber mainly differs from Medicare.gov in the amount of time it takes for a user to go through the search process.

This is mainly because the starting questionnaire is shorter, but its drug-finding tool is also simpler. Instead of asking users to enter the full drug name, the system will request only the drug's first three letters. Once the letters are in, the drugs have been narrowed down and a clickable list of options appears directly underneath the letters.

You can select your dosage, and then you will be taken to a comparison screen. A prompt will ask you whether you would like an agent to call you and help you sort through the health plans. If you decide you want to continue browsing options yourself, you will be able to compare plans in a separate tab, three at a time.

ExtendHealth.com

Extend Health, owned by human resources consulting firm Towers Watson, entered the consumer market during the last Medicare enrollment period, but the company has been helping seniors find drug plans for about eight years through its relationships with employers. Extend Health has partnered with Fortune 500 companies, including Chrysler and General Motors, to reach employees. If you belong to a company that works with Extend Health, your employer may mandate that you work only with this broker.

The process is simple, though. Retirees receive a mailer, which asks them to select a date and time that they would like an adviser to call them. They can also go through the process online, and compare up to five plans against one another. The company invests heavily in setting up people with brokers over the phone. The conversations will last an average of 23 minutes, says Williams, adding that seniors generally prefer to complete these enrollments over the phone.

Keep in mind that agents from PlanPrescriber or Extend Health may call you about their product offerings if you enter your personal information in their websites. 

http://www.everydayhealth.com/news/how-medicare-beneficiaries-can-save-money-prescription-drugs/

Last Updated: 10/15/2014

Breaking the Seal on Drug Research

Breaking the Seal on Drug Research

Steve Ruark for The New York Times

Peter Doshi, in background, wants to give consumers “the full picture” on drug data. He shared an article with Kevin Fain in a Johns Hopkins cafe.

By KATIE THOMAS

Published: June 29, 2013

PETER DOSHI walked across the campus of Johns Hopkins University in a rumpled polo shirt and stonewashed jeans, a backpack slung over one shoulder. An unremarkable presence on a campus filled with backpack-toters, he is 32, and not sure where he’ll be working come August, when his postdoctoral fellowship ends. And yet, even without a medical degree, he is one of the most influential voices in medical research today.

Related

• The Cochrane Collaboration (June 30, 2013)

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Cochrane Archive, Cardiff University Library, University Hospital Llandough

Archie Cochrane, an influential British epidemiologist.

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Julia Yellow

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Chris Warde-Jones for The New York Times

Tom Jefferson, an epidemiologist, worked with Dr. Doshi in reviewing research about Tamiflu’s effectiveness.

Dr. Doshi’s renown comes not from solving the puzzles of cancer or discovering the next blockbuster drug, but from pushing the world’s biggest pharmaceutical companies to open their records to outsiders in an effort to better understand the benefits and potential harms of the drugs that billions of people take every day. Together with a band of far-flung researchers and activists, he is trying to unearth data from clinical trials — complex studies that last for years and often involve thousands of patients across many countries — and make it public.

The current system, the activists say, is one in which the meager details of clinical trials published in medical journals, often by authors with financial ties to the companies whose drugs they are writing about, is insufficient to the point of being misleading.

There is an underdog feel to this fight, with postdocs and academics flinging stones at well-fortified corporations. But they are making headway. Last fall, after prodding by Dr. Doshi and others, the drug giant GlaxoSmithKline announced that it would share detailed data from all global clinical trials conducted since 2007, a pledge it later expanded to all products dating to 2000. Though that data has not yet been produced, it would amount to more than 1,000 clinical trials involving more than 90 drugs, a remarkable first for a major drug maker.

The European Medicines Agency, which oversees drug approvals for the European Union, is considering a policy to make trial data public whenever a drug is approved. And on June 17, the medical world saw how valuable such transparency could be, as outside researchers published a review of a spinal treatment from the device maker Medtronic. The review, which concluded that the treatment was no better than an older one, relied on detailed data the company provided to the researchers.

For years, researchers have talked about the problem of publication bias, or selectively publishing results of trials. Concern about such bias gathered force in the 1990s and early 2000s, when researchers documented how, time and again, positive results were published while negative ones were not. Taken together, studies have shown that results of only about half of clinical trials make their way into medical journals.

Problems with data about high-profile drugs have led to scandals over the past decade, like one involving contentions that the number of heart attacks was underreported in research about the painkiller Vioxx. Another involved accusations of misleading data about links between the antidepressant Paxil and the risk of suicide among teenagers.

To those who have followed this issue for years, the moves toward openness are unfolding with surprising speed.

“This problem has been very well documented for at least three decades now in medicine, with no substantive fix,” said Dr. Ben Goldacre, a British author and an ally of Dr. Doshi. “Things have changed almost unimaginably fast over the past six months.”

Much of that change is happening because of what Dr. Goldacre calls an “accident of history.” In 2009, Dr. Doshi and his colleagues set out to answer a simple question about the anti-flu drug Tamiflu: Does it work? Resolving that question has been far harder than they ever envisioned, and, four years later, there is still no definitive answer. But the quest to determine Tamiflu’s efficacy transformed Dr. Doshi and others into activists for transparency — and turned the tables on drug makers. Until recently, the idea that companies should routinely hand over detailed data about their clinical trials might have sounded far-fetched. Now, the onus is on the industry to explain why it shouldn’t.

IN summer 2009, Dr. Doshi received a call from Dr. Tom Jefferson, a British epidemiologist based in Rome. That year, the swine flu pandemic was spreading worldwide, and Dr. Jefferson had been hired by the British and Australian governments to update an earlier review of Tamiflu, a drug produced by the Swiss company Roche, aimed at reducing the flu’s severity and preventing more serious complications. He asked if Dr. Doshi wanted to help.

Determining Tamiflu’s efficacy had significant economic as well as health consequences. Around the world, private companies and governments — including that of the United States — were stockpiling Tamiflu in case of influenza outbreaks, and their spending accounted for almost 60 percent of the drug’s $3 billion in sales in 2009.

The review of Tamiflu was being conducted under the auspices of the Cochrane Collaboration, a well-regarded network of independent researchers, including Dr. Jefferson, who evaluate medical treatments’ effectiveness by analyzing all available research.

At the time, Dr. Doshi knew little about clinical trials or even much about the drug industry. But he knew Dr. Jefferson. Dr. Doshi, after receiving undergraduate and master’s degrees in anthropology and East Asian studies from Brown and Harvard, had shifted focus and was pursuing a doctorate at M.I.T., studying the intersection of medicine and politics. He met Dr. Jefferson, a prominent skeptic of the flu vaccine, after researching whether the Centers for Disease Control was exaggerating the deadliness of the disease.

“We were both lone wolves in the field of influenza,” Dr. Doshi recalled.

Dr. Jefferson had conducted a Cochrane review of Tamiflu’s effectiveness a few years earlier, concluding that the drug reduced the risk of complications from the flu. He assured Dr. Doshi and other researchers on his team that the update would be fairly simple.

But just as their work was getting under way, a simple comment arrived on the Cochrane Web site that changed the course of the research and would ultimately fuel a worldwide effort to force drug companies to be more transparent.

The author of that comment, Dr. Keiji Hayashi, had no connection to the Cochrane group; he was a pediatrician in Japan who had prescribed Tamiflu to children in his practice, but had come to question its efficacy. He was curious about one of the main studies on which Dr. Jefferson had relied in his previous analysis. Called the Kaiser study, it pooled the results of 10 clinical trials. But Dr. Hayashi noticed that the results of only two of those trials had been fully published in medical journals. Given that details of eight trials were unknown, how could the researchers be certain of their conclusion that Tamiflu reduced risk of complications from flu?

“We should appraise the eight trials rigidly,” Dr. Hayashi wrote.

Reviews by the Cochrane group are known for being among the most thoroughly researched medical analyses available. But in trying to answer the pediatrician’s question, Dr. Jefferson realized that there was a flaw: they relied too heavily on the assumption that the articles published in journals accurately represented the results of all clinical trials that had been conducted.

As he tried to track down the authors of the Kaiser study and the two published trials, Dr. Jefferson said he hit dead ends: One author said he had moved offices and no longer had the files; another said he had never seen the primary trial data, instead relying on a summary analysis provided by Roche. All the authors suggested that he contact the company.

“We took it on faith — on trust,” Dr. Jefferson, 59, said recently in a phone interview. Dr. Hayashi’s question had tested that faith. Dr. Jefferson began typing each new discovery in a private journal he called Hayashi’s Problem, which, he said, “charted my transformation from Dr. Jekyll to Mr. Hyde.”

Dr. Doshi said that medicine “relies on hierarchies of trust.” He added: “A patient is not going to be in a position to review the entire evidence base themselves. But they trust that there is a watchdog out there.”

As they dug into the Tamiflu research, Dr. Doshi said, he realized that such a watchdog didn’t exist. Instead, he said, “we have partial watchdogs who see part of the full picture.” It became his mission to see the full picture.

Having struck out with the authors of the disputed Kaiser paper and the two other published trials, Dr. Jefferson approached Roche itself, asking for the underlying data from the missing trials. But when he declined to sign a confidentiality agreement, Roche decided not to cooperate with the researchers.

Without more complete data about the clinical trials, the Cochrane group decided that it could not include the disputed study that summarized those results. In December 2009, the team reported that Tamiflu could not be shown to reduce complications like pneumonia or hospitalizations.

The British Medical Journal, which printed the team’s conclusions, also published its own investigation, showing that Roche had hired ghost writers to author some of the articles involving Tamiflu, and that those writers had said they were under pressure to highlight positive messages about the drug. Roche responded that hiring such writers was common industry practice at the time of the articles, and it rejected the idea that they had been pressured to write positively about the drug.

The articles in the British journal created a sensation, and the Cochrane Collaboration’s efforts became a cause célèbre. “Everyone knows about publication bias,” said Dr. Steven Woloshin, a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice and an advocate of more widespread sharing of clinical trial data. “But they just had so much energy and they brought so much attention to it.”

The group’s efforts seemed to make a difference: After the articles in the British journal, Roche turned over partial copies of study reports, amounting to a little more than 3,000 pages. Then, in 2011, the European Medicines Agency turned over more than 22,000 pages of documents for 19 trial reports to Dr. Jefferson and his team.

The door had been opened. As they read through the records, the researchers discovered the importance of documents called clinical study reports, which are thousands of pages long and contain details as varied as descriptions of trial protocol and design and the ingredients of the placebo pills.

“We used to know that there was a published paper and there were data behind it,” said Dr. Fiona Godlee, the editor of the British Medical Journal. “But people haven’t talked about these things, like clinical study reports, that are now being talked about a great deal.” Last fall, the journal said it would publish the results of clinical trials only if drug companies and researchers agreed to provide data upon request.

In April, Roche said it would make available to the Cochrane researchers clinical study reports for all Roche-sponsored trials of Tamiflu. Dr. Jefferson, Dr. Doshi and their colleagues hope to complete another update to their review of the drug by year-end.

Some said it was a shame that it took this long for the company to relent. “All these years later, and we still don’t know if Tamiflu is effective,” said Dr. Harlan Krumholz, the Yale cardiologist who oversaw the review of Medtronic’s bone treatment. “It’s perplexing to have a billion-dollar drug, and you’re still not willing to share everything you’ve got to know whether this thing is effective and safe.”

THOUGH the Tamiflu question is not yet resolved, the Cochrane researchers have succeeded in a bigger way: by helping to change the conversation around companies’ responsibility to reveal drug trial data.

Drug companies do not always credit the Cochrane Collaboration. In February, Roche followed Glaxo’s lead and announced that it, too, would release detailed clinical data to outside researchers, upon request. But Daniel O’Day, chief operating officer of pharmaceuticals at Roche, denied that its pledge had been motivated by the Tamiflu experience. He said Roche has provided data to “thousands” of researchers.

Mr. O’Day said “there were probably errors on both sides” in how the Cochrane researchers and Roche communicated with each other, and said the relationship deteriorated after Dr. Jefferson refused to sign a confidentiality agreement. He said the company was trying to rebuild its relationship with the Cochrane researchers, but that it stood by the safety and efficacy of Tamiflu.

In 2010, Roche commissioned researchers at the Harvard School of Public Health to conduct a re-analysis of Tamiflu clinical data, which largely confirmed the positive conclusions of the Kaiser study.

Mr. O’Day asserted that the company’s transparency pledge had arisen from “the call from society in general for greater transparency of the clinical trials that we have.” But others say the Cochrane researchers are largely responsible for that call for transparency.

Andrew Witty, Glaxo’s C.E.O., said in an interview that his promise to provide detailed clinical data had grown out of a companywide effort, initiated soon after he became chief in 2008, that would “really ensure that we were more in step with where I thought, frankly, society and the world was moving.”

Glaxo, moreover, was in need of an image rehabilitation. Last year, it pleaded guilty to criminal charges and agreed to pay $3 billion in fines after the United States Justice Department accused the company, based in London, of failing to report safety data about its diabetes drug Avandia, and of publishing misleading information about Paxil, the antidepressant, in a medical journal. The settlement, which also included civil penalties over marketing of other drugs, was the largest ever involving a pharmaceutical company.

“We don’t see any reason for this information to be held out of the public domain,” Mr. Witty said, “provided that the people who are interrogating the information are legitimate researchers with a legitimate question to ask.”

In a twist, Roche now finds itself on the same side as the Cochrane researchers — and against many in its own industry — in a debate over what kind of data the European Medicines Agency should be making public. On Monday, the agency released a draft policy, expected to take effect next year, in which it would release clinical trial data whenever it approved a new drug. While Roche and Glaxo have supported the policy, the Pharmaceutical Research and Manufacturers of America, a major industry group, and other drug companies have opposed it.

John J. Castellani, chief executive of PhRMA, said the industry had championed open-source efforts to develop better methods for testing cancer drugs, for example. But proposals like those from the Cochrane team and the European agency go too far, he said.

“If you dump onto the sidewalk all the data and you include commercially protected information,” he said, “then you’re essentially giving to competitors what we invested billions of dollars in.”

Others warned that such a policy could discourage drug companies from investing in Europe. “If you, on the other hand, say, ‘You guys are bad actors, we want to cut your prices, we want to take your confidential data and share it with any one of your competitors,’ you don’t get the same feeling of encouragement,” Christopher A. Viehbacher, C.E.O. of the French pharmaceutical company Sanofi, told reporters in Brussels on Monday, according to Reuters.

Industry officials and regulators in the United States say the public already has access to vast amounts of information about clinical trials. The basic results of all clinical trials must now be registered in a federal clearinghouse, for example, and the Food and Drug Administration publishes staff reviews and other documents when it approves a new drug. The F.D.A. has said that it is monitoring the developments in Europe but that federal laws in the United States restrict what types of information can be released, particularly data that could reveal personal or commercially confidential information.

Cochrane group members point to the Medtronic study as an example of the value of a neutral perspective.

In 2011, Medtronic awarded a $2.5 million grant to Yale and asked it to oversee a detailed review of trial data for Infuse, a bioengineered material in spinal fusions to treat back pain. The company was facing claims that it had published misleading information about the treatment, and it turned over its data in an effort to address those criticisms. Two teams that examined the data came to similar conclusions: Infuse appeared to be no better than an older treatment, and may pose added risks.

EARLIER this month, Dr. Doshi opened what he hopes will be a new chapter in his quest for greater understanding of clinical trials. He and several other researchers published what amounted to an ultimatum to drug companies: publish your data, or we’ll do it for you.

Under the plan, researchers would publish articles summarizing trial results in cases where the underlying data has already been released. In isolated cases, such information has been made public through litigation and Freedom of Information Act requests.

“It’s really neat to see a larger opportunity for a larger impact,” he said. “Tamiflu just happened to be the lever that opened that door.”

http://www.nytimes.com/2013/06/30/business/breaking-the-seal-on-drug-research.html?pagewanted=all&_r=0

Patients need drug options, not limitations By Michael J. Fitzpatrick, executive director, National Alliance on Mental Illness - 07/09/12 02:50 PM ET Imagine being sick with a life-threatening disease. Most of us would want access to as many medicines as possible -- including the full range of proven treatment options. But under the Affordable Care Act, some people may see their drug choices severely restricted. A draft regulation proposed by the Department of Health and Human Services would require insurers participating in the law's new exchanges to cover only a single drug in each class of pharmaceuticals. That could be a disaster for both patients and doctors. Those living with chronic conditions -- think serious mental illness, HIV-AIDS, epilepsy, or kidney disease -- would be hit particularly hard. "One-size-fits-all" may work for baseball hats, but medication requires a far more individualized approach. Doctors know that each patient responds differently to treatment. Patients need all the options they can get. That's part of the reason Medicare's prescription drug benefit has been so important. Medicare Part D requires participating plans to cover at least two different drugs in most every class of pharmaceutical -- and nearly all drugs in six important classes: immunosuppressants, antidepressants, antipsychotics, anticonvulsants, antiretrovirals, and antineoplastics. Medicare Part D's requirements were designed to ensure continuity and access for vulnerable patients. Its rules should be a model for the new regulation. Similar drugs within the same category can have dramatically different results among patients. A drug that works for your neighbor might not work for you . Choice works in tandem with innovation to give patients the best chance of recovery. Requiring insurers to cover just a single drug in each class would likely cause many to skip covering new drugs, even if they represent clinical improvements in efficacy and/or safety. This issue is especially important for the mental health community. Diagnoses in serious mental illness remain imprecise. It is not uncommon for a patient to receive multiple inaccurate diagnoses over several years before being correctly diagnosed and receiving effective treatment. Persons with depression, bipolar disorder, or schizophrenia don't always respond to their first or second rounds of treatment -- and often require multiple attempts with multiple combinations of medications before something finally succeeds. There's no way of knowing in advance exactly what will work. This is why doctors and patients need all available options. Research into drug access for Medicaid beneficiaries starkly illustrates the problem of restrictions on medicines. According to one recent study, psychiatric patients with medication access issues had three times the rate of suicidal thoughts and behavior. When these patients were forced to switch drugs because of a lack of coverage, they reported far higher rates of hospitalization, homelessness, and incarceration. When it comes to prescription drug coverage, what patients need most is access and choice. The Department of Health and Human Services understands this issue. Indeed, this same draft regulation about the healthcare law's exchanges contains strong language ensuring "mental health parity," which requires insurers to cover both mental and physical health equally. Prescription drug coverage should not fall short of this standard for equitable coverage. The Department of Health and Human Services is expected to make its final ruling on drug access in the insurance exchanges within the next two weeks. Between now and then, it's imperative that Department officials revise this regulation to protect patients. Fitzpatrick is executive director at NAMI, the National Alliance on Mental Illness. Source: http://thehill.com/blogs/congress-blog/healthcare/236763-patients-need-drug-options-not-limitations

Drugging our kids, Suicide & homicide effects CASPER. MR NEWS

I’d like to share a very interesting and informative YouTube presentation.  While lengthy in its presentation it gives one much to think about. 

http://www.youtube.com/watch?v=5bu1uApqIr4&feature=player_embedded

Warmly,

Herb
vnsdepression@gmail.com
http://www.vnstherapy-herb.blogspot.com/

Watch Out! At FDLI Conference, Government Says More People Will Be Convicted of Crimes

October 14, 2010

Watch Out!  At FDLI Conference, Government Says More People Will Be Convicted of Crimes

By Douglas B. Farquhar –
At a trade industry conference this week, a cadre of government officials unanimously predicted a dramatic increase in the number of criminal prosecutions of individuals for violations of laws governing FDA-regulated industries.  They also discussed how the types of prosecutions may be shifting away from charges based on off-label promotion of drugs and medical devices to charges based on threats to the safety and efficacy of FDA-regulated products, which include food, tobacco, medical devices, and drugs.

I was a co-chair of the conference, which was sponsored by the Food and Drug Law Institute (“FDLI”) in Washington, D.C., along with Jennifer Bragg of the law firm Skadden, Arps, Slate, Meager & Flom.  The Annual FDLI Enforcement Conference gathers together as speakers the decision-makers on enforcement and compliance from all of the major Centers at FDA (Food, Medical Devices, Advertising and Promotion, Drugs, Veterinary Drugs, and Biologics), the top enforcement officer for the agency (Eric Blumberg, FDA Deputy Chief Counsel for Litigation) and the head of the Office of Consumer Litigation, the litigating arm for FDA at the federal Department of Justice (Eugene Thirolf).

In what was probably the most concentrated collection of enforcement speakers gathered at an industry event, nearly all of the speakers predicted an increase in the number of prosecutions of individuals for violations of the Federal Food, Drug, and Cosmetic Act, the statute that governs manufacture and distribution of FDA-regulated products.  The Conference focused on strict-liability prosecutions under the so-called Park doctrine (also covered in an HPM-sponsored webinar last week), and the officials predicted an increase of prosecutions of responsible corporate officials, even if there is no proof that they participated in, encouraged, or even had knowledge of the violations.  Speakers from the government, industry, and private law firms (that would include yours truly) discussed how it is imperative that top corporate officials implement policies and procedures that effectively prevent violations from occurring, with a special emphasis on ensuring that no unapproved claims are made in promotional materials for drugs and devices, that reports of safety problems are filed with FDA promptly and accurately, that officials do not ignore problems discovered in testing of manufactured products, and that drugs and devices are manufactured in accordance with regulations setting current Good Manufacturing Practice.

The trade press has already reported that the government may especially be looking at prosecuting officials for off-label promotion because they feel that the huge monetary settlements with drug and device companies (reportedly more than $9 billion in the last ten years) are not getting the job done.
In addition:

• Blumberg indicated that he expects that criminal investigations will focus on distribution of unapproved new drugs, failure to report unexpected adverse events caused by medical products, and “flagrant” off-label promotion (that is, advertising, company-sponsored programs, pitches by sales reps, and other promotional material which encourages the use of the products for conditions or treatments other than those approved in the labeling).
• Each of the FDA Center compliance directors reported that they are cooperating much more closely with FDA’s Office of Criminal Investigations.
• Howard Sklamberg, Director of FDA’s Office of Enforcement, noted that Class I recalls (the most serious category of recalls) will generally lead to increased FDA inspections and scrutiny of an FDA-regulated company.
• Thirolf mentioned that he anticipates seeing more criminal investigations and prosecutions focused on safety issues, rather than just off-label promotions.  He confirmed, in response to a particularly astute question (that would be from me) that safety issues include distribution of defective products, failure to report adverse events, and fraudulent reporting of testing data or false documentation of manufacturing processes and procedures.

One of the speakers also said that there were 70 whistleblower cases that were filed last year against device and drug companies that are currently being investigated by the federal government.

For more information about the conference, or to get a copy of a CD audio recording of the proceedings, visit www.fdli.org.

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2010/10/watch-out-at-fdli-conference-government-says-more-people-will-be-convicted-of-crimes.html