I debated — or rather tried to debate — Families USA’s Ron Pollack yesterday at a Mercatus Center luncheon briefing for congressional staff on whether to lift the ban on price controls in Medicare. Mercatus usually wants the person proposing change — in this case it was Ron since he wants to impose price controls on Medicare drug purchases - but Ron had asked if I could go first since he wanted a chance to eat his chicken wrap, salad and cookies. No problem, since I had eaten a protein bar beforehand.

I tried getting him to explain why he was for a drug plan that did not include price controls in 2000 and was opposed to the same kind of plan now. It’s okay to change your mind, after all. Though I asked Ron 7 times during our exchange about his flip-flop he never addressed the issue. The same goes for how he can categorize as negotiations a system that requires biotech and drug companies to give the VA a 24 percent discount below wholesale price or lower or be barred from dealing with Medicare, Medicaid and the Public Health Service is a “neogtiation”. Never explained that either. Like a robot programmed to stick to two messages, insulting my intelligence (I had called him a hypocrite in my American Spectator article so I wasn’t expecting compliments ) or trying to con people into believing that a federal law requiring price discounts and no price increases above the CPI is a negotiation, Ron just ignored my questions.

He took issue with a study by Frank Lichtenberg that demonstrated that for every dollar spent on new drugs to treat a medical condition, Medicare and consumers will save nearly 8 by not using more invasive medical procedures. He thought the conclusions absurd though he never read the paper. Here’s my source and a link to the paper itself: “For the Medicare population, average medical expenditure per condition is 57 percent higher ($1,286 versus $817) than for the entire population. Thus the savings from newer drugs are also somewhat higher. The total prescription drug expenditure per medical condition will increase by about $21,but the reduction in total non-drug spending per condition falls $176, yielding a $155 net reduction. Hospital cost reduction accounts for 58 percent of the savings ($102). Home health care is trimmed $37, and office visits $34.” (http://papers.nber.org/papers/w8996)

Typically, he called the Lichtenberg study, which is in a peer-reviewed economics journal, a “Phrma financed study.” I have no idea if it was or not. In any event, he didn’t take kindly to my pointing out that the substance was more important than who financed it just as his receiving funding from currency wrecker George Soros should not divert attention from his basic message.

I don’t think Ron and I will be having lunch again anytime soon.

Per this morning’s press conference (see blog below), an additional point — PhRMA has stepped up to the plate and hit a solid series of singles with their voluntary guiding principles. It’s time for the FDA to step out of the batter’s box and take a few swings.

Remember in the not-too-recent past many blustering elected officials regularly called the threat of counterfeit prescription medicines a “ploy” by the pharmaceutical industry? Well, they ain’t bloviating these days. Consider this frightening piece of news that has just crossed the wire …

DETROIT — The U.S. Attorney’s Office today indicted 18 people it alleged took part in a multimillion-dollar international conspiracy to smuggle cigarettes and counterfeit Viagra to raise money for the Mideast terrorist group Hezbollah.

“The enterprise operated from Lebanon, Canada, Brazil, Paraguay, China, North Carolina, Florida and the Dearborn, Michigan area, perpetrating crimes in the states of Michigan, California, Florida, Georgia, Illinois, North Carolina and West Virginia (and points in between),” the indictment alleges.

Unfortunately this is part of a dangerous global trend. The EU recently went on the record (again) with its concern about the rise of counterfeit drugs in Europe (see 3/28 drugwonks.com blog entry) and Canadian authorities reported that they have made arrests in their on-going “Project Piranha,” seizing a Hell’s Angels gang’s supply of marijuana, hashish — and counterfeit prescription drugs (see 3/25 drugwonks.com blog entry).

When, two years ago, the FDA stated publicly that counterfeit drug schemes were being used to fund global terrorist organizations, certain governors and members of Congress accused the agency of “being in the pocket of Big Pharma.” Well, they are strangely silent today.

And I don’t believe in coincidences.

The New England Journal of Medical Opinion is running an editorial about the Medicare drug benefit by one of the Harvard Medical School’s Repository of Liberal Thinking on Healthcare, Jerry Avorn. The article is entitled “D is for Defective” and can read by going to http://content.nejm.org/cgi/content/full/354/13/1339?query=TOC. And if the article is not enough stimulation, the NEJM has a real treat for you: an audio interview with Dr. Avorn so you can experience his smugness in stereo. I wrote a letter to Avorn challenging him to crawl out of his elite cocoon and debate me on Medicare Part D. Fat chance.

Dear Mr. Avorn:

I read your editorial on the Medicare drug benefit (Part D for Defective) in the NEJM with great amusement. It reminded me of what Mark Twain once said: Get the facts straight and then distort them as you please. Then again, you don’t even get the facts straight.

Perhaps that’s because you rely solely on media accounts of the program design and implementation instead of information readily available about these issues as far back as November of 2004. You would then know as an article in Health Affairs pointed out that the the president “proposed an outpatient prescription drug benefit to be offered under a new voluntary Part D of Medicare … Medicare would pay half the cost of covered drugs The drug benefit would be administered by a [private] pharmacy benefit manager.” To help seniors maintain more generous private-sector coverage, “the president’s proposal had incentives for employers to keep [drug coverage]. Medicare would pay employers 67 percent of the premium subsidy costs it would have incurred if retirees had enrolled in Part D instead.”

This is what you are railing against and you claim that it is a product of “heavy input from pharmaceutical and insurance industries, with predictable results.” In fact, the program described in the Health Affairs article was Bill Clinton’s. It was supported by virtually every Democrat. At the time, President Clinton noted that his program, “competitively selects private benefit manager to deliver the benefit to enrollees in the traditional program,” and instead of “government negotiating directly for prices (price controls) the new benefit has privately-negotiated discounts, gained by pooling beneficiaries’ purchasing power, for all drug expenses.”

Did I miss your _expression of outrage about Medicare chaos at that time?

Note that both the Clinton and Bush plan enrolled all seniors to avoid what is known as adverse selection. That means — though you are a single payer fan and should get the drift — that if the drug benefit was only offered to those without coverage the risk pool would be filled with the sickest and most poor. Enrolling everyone and providing subsidies to encourage employers to retain coverage was a way to spread risk and promote wider participation.

I agree the goal was to enroll those 11 million seniors — including the 7 million that are low income or spend more than $3600 in medicines to enroll. And it seems they are. Nearly 8 million have already, about half of them being those in greatest need and deriving the greatest benefit. By the time May 15 rolls around I will bet you a donut that most of the people that need it will be enrolled. That will be in stark contrast to the dismal record of the state plans you and Ron Pollack said were just as good. Again, since you only seem capable of getting your facts second hand, let me give you information on those state pharmaceuetical assistance programs from the Commonwealth Fund. It found that in 2000, 15 state program enrolled only 19 percent of eligible people, or less than a million. Overall, after a quarter century of operation, the state plans had enrolled an average of 30 percent of all income eligible seniors. No wonder that when it came to shifting Medicaid seniors over to Medicare, states in some instances dropped the ball.

As for the donut hole, you should know that seniors have a choice of choosing plans that fill it completely. Indeed, more than 20 percent have. And then they also can choose to join a managed care plan which eliminates your other concern, that the drug benefit is carved out and handed off to a separate entity that would appear to be only interested in saving the costs of the drug. But you never seem to endorse that. Rather, you call for government controlled, universal drug coverage with technocrats — perhaps using programs developed by you — deciding which drugs to use and which to refuse to administer. And you call for price controls as well. You call them negotiations. But we have seen how negotiations work in the VA, Canada and elsewhere. Name me one system where drug prices are negotiated and the government is the single payer where the government also does not withhold access to medicines or refuse to pay for them regardless of benefit.

In this regard your pretense of scientific objectivity is just that and nothing more. For all of your pompous prattle about evidence based prescribing, your support of government direct negotiating undercuts such an approach. The VA formulary only includes 22 percent of all FDA priority review medicines on its formulary. It excludes Gleevec, Alimta, Humira, Avastin, etc. You blather on about the ALLHAT study when specialists in hypertension community have largely rejected the one size fits all approach you have read into it. Further, in an era of personalized medicine, which you never mention since it does not square with your command and control approach to prescribing, large scale randomized trials are scientifically deficient since they by definition exclude inclusion of any mechanistic understanding of how a drug works or how that mechanism (as a result of genetic polymorphisms) may shape treatment and drug response in subpopulations. Yet, your whole campaign to make drug choices based on safety, efficacy and economic value depends on the creation of a government agency that would fund larger and longer comparative trials that would by definition have no room for the personalization of medical care. So much for allowing doctors to “choose the most appropriate and cost-effective drug…”

I would challenge you to a debate on these issues but I doubt you would give up the intellectual free ride you have been given by your friends in the media. I don’t doubt that you actually believe that you possess some absolute truth about all health matters. And I don’t doubt that many of your allies feel the same way about themselves and that the sentiment, when you are all together, is mutually reinforcing. But that does not constitute reality or even truth. If you ever feel the urge to step outside the circle of hubris to discuss these matters, please let me know.

Sincerely,

Robert M. Goldberg, PhD.
Vice President
Center for Medicine in the Public Interest

Latest release on the FDA website (truncated by me, with the full verbiage at www.fda.gov).

FDA’s Accomplishments in 2005

Innovative Technology

The FDA made progress in implementing its Critical Path initiative, a pioneering project that seeks to apply the best available science to the medical product development process by creating novel tools — such as proven biomarkers and simulation models — for assessment of the safety and effectiveness of drugs and medical devices.

As part of this initiative, the FDA conducted a workshop with The Drug Information Association and The Biotechnology Industry Association to discuss ways of routinely using new imaging techniques in drug development. The agency also created a non-regulatory pathway for discussions with sponsors about certain issues involving submission and use of pharmacogenomic data; concluded an agreement with BG Medicine, a biotechnology research company, to collaborate on discovering signs of liver toxicity in the initial stages of drug development; and published a final guidance on the development of pharmacogenomic data that could help predict the optimum treatment for each individual patient.

Patient and Consumer Protection

The FDA launched several initiatives to reform and make more transparent the system that protects patients from adverse events associated with marketed drugs. The steps taken in 2005 included a contract with the Institute of Medicine to study the effectiveness of the U.S. drug safety system; the appointment of 31 top drug experts to a novel Drug Safety Oversight Board that oversees the management of important drug safety issues; and four contracts to improve FDA’s access to databases that can help identify rare side effects of medicines. Other examples of patient and consumer safety-oriented projects included FDA’s investigation of the mechanical strength of vertebrae following injections with bone glue, the most common treatment for compression fractures that affect a quarter of all women over the age of 50; and studies of the toxicity of acrylamide in food.

FDA made important contributions to the nation’s preparedness for the potential influenza pandemic. The agency provided guidance to speed vaccine manufacturing and availability; sought to increase the number of vaccine manufacturers and their capacity; and addressed such needs as the creation of pandemic strain libraries, for use in vaccine manufacturing and development, and improved assays and testing.

Bioterrorism

To help protect the nation against bioterrorism, Congress has charged the FDA with helping to secure the food supply and encouraging the development and availability of counter-terrorism medical products. As part of this program, the FDA last year strengthened the protection against the effects of inhaled anthrax by approving several generic versions of Cipro (ciprofloxacin). The agency also approved ThyroShield (potassium iodide oral solution) for use in radiation emergencies and developed draft guidance on studies of products to eliminate inhaled, absorbed, or ingested radioactive contaminants.

CFSAN, along with the U.S. Department of Agriculture, the Federal Bureau of Investigation, and the Department of Homeland Security, announced a new collaborative effort with states and private industry to protect the nation’s food supply from terrorist threats through the Strategic Partnership Program Agroterrorism Initiative. CFSAN has spearheaded this effort to identify sector-wide vulnerabilities, mitigation strategies and research needs to protect our nation’s food supply.

Better Manufacturing Practices

Another major FDA priority in 2005 was to ensure the proper manufacture of medications by strengthening compliance with the recently overhauled pharmaceutical standards Good Manufacturing Practices (GMPs). An example of this emphasis has been the agency’s close cooperation with the United Kingdom’s Medicines and Health Products Regulatory Agency (MHRA) in ensuring the correction of sterility failures that had caused the MHRA to suspend the license for Chiron, a major producer of influenza vaccine for the United States.

Both FDA and MHRA provided extensive input on Chiron’s remediation plan for the firm’s facility in Liverpool, and repeatedly inspected its implementation. The joint efforts resulted in the release and delivery of the Fluvirin influenza vaccine to the United States for the 2005-2006 influenza season.

Modernizing FDA

To help protect patients from medication errors, to better inform practitioners about the information they need to use products most safely, and to better enable the use of electronic labeling of drug and biologic products, FDA finalized its new rules governing the format and content of the required information (labeling) that must accompany drug and biologic products when they are marketed in the United States.

Note to Senator Grassley: Please feel free to send a thank-you note to the hard working men and women of the FDA.

“Doctor experienced in bird flu doubts forecast pandemic”
NY Times, March 28, 2006

“U.N. expert says bird flu virus has him “quite scared”
NY Times, March 28. 2006

I guess this is what’s called “balanced” reporting.

No matter how you say it, prescription drug counterfeiting is international health care terrorism

(And so much for certain US politicians who claim that Europe has no problem with counterfeiting.)

EU Says Counterfeit Drugs On The Rise In Europe

BRUSSELS (AP) — An increasing amount of fake drugs is being sold over the Internet in Europe, the European Union warned Monday.The European Commission said a recent survey conducted by E.U. member states, identified 170 fake medicines that were being distributed illegally, mostly through Web sites offering fake or unauthorized lifestyle drugs, growth hormones and sleeping drugs … “I am alarmed at the ever increasing number of counterfeit medicines sold via the Internet. This represents a real danger to the health of patients,” said E.U. Enterprise Commissioner Guenther Verheugen.Lifestyle drugs, such as Viagra, and essential medicines such as antibiotics and insulin are particularly popular with counterfeiters, but there’s also an increasing number of fake contact lenses and even materials such as surgical mesh. Experts warned buying health products over the Internet can be a major health risk.

An excellent article in today’s edition of the Chicago Sun-Times on the strides we are making towards making acute diseases chronic conditions. Here’s a sample:

In the last 25 years, the death rate from heart disease has been cut in half. On another front, the number of cancer deaths recently dropped for the first time in more than 70 years. Yet heart disease and cancer together still kill more Americans than all other causes of deaths combined. Researchers are developing high-tech new treatments such as targeted cancer drugs and stem cell heart therapies.

But the best way to fight the Big Killers is to not get sick in the first place. If we all simply took better care of ourselves, experts say, we could cut the death toll from cancer and heart disease by at least 50 percent.

It’s worth a read. Here’s the link: http://www.suntimes.com/output/health/cst-nws-kill261.htm

Caroline Kovac (IBM’s Princess of Prescience) on what Big Pharma can learn from Big Blue:

“Replace the word blockbuster with mainframe and then we can talk.”

Nope, not a mixed metaphor. I just returned from Brussels where I spoke on what the Europeans call “information to patients” or “ItP” (what we heathens on this side of the Atlantic refer to as “direct to patient communications”). The event was at the Amigo Hotel. (For you trivia buffs, this hotel used to be a prison — and one of its most famous guests was Karl Marx.)

I spoke on the American experience with DTC advertising (both the pros and the problems) and my fellow panelist, James Copping, talked about how the EU is trying to figure out what to do next, since “not American-style drug advertising” is not a go-forward policy. Jim’s a player. He’s the Principal Administrator for the EU’s Enterprise and Industry Directorate-General, the body drafting the EU’s go-forward recommendations.

One interchange between Jim and me that is worth sharing:

COPPING: “We must find new ways to regulate health care information to patients.”

PITTS: “Jim, I think a better way to frame the question is to say that you need to find new ways to facilitate health care information to patients.”

COPPING: “Yes, that’s right.”

God’s speed Mr. Copping.

Here’s an exciting timely and important new paper on what antihypertensives have accomplished and what more could be accomplished if people were treated to guideline. It’s a clarion call to address our nation’s (indeed the globe’s) chronic health care problem — ignoring the urgency of focusing on chronic care.

The Impact of Antihypertensive Drugs on the Number and Risk of Death,
Stroke and Myocardial Infarction in the United States by Genia Long,
David Cutler, Ernst R. Berndt, Jimmy Royer, Andree-Anne Fournier, Alicia
Sasser, Pierre Cremieux #12096 (AG HC)

Abstract:

Estimating the value of medical innovation is a continual challenge.

In this research, we quantify the impact of antihypertensive therapy on U.S. blood pressures, risk and number of heart attacks, strokes, and deaths. We also consider the potential for further improvements.

We estimate the value of innovation using equations relating blood pressure to adverse outcomes from the Framingham Heart Study. Our results show that without antihypertensive therapy, 1999-2000 average blood pressure for the U.S. population age 40 plus would have been 10-13 percent higher. 86,000 excess premature deaths from cardiovascular disease (2001), and 833,000 hospital discharges for stroke and heart attacks (2002) would have occurred. Life expectancy would be 0.5 (men) and 0.4 (women) years lower. At guideline care, there would have been 89,000 fewer premature deaths (2001) and 420,000 fewer hospital discharges for stroke and heart attack (2002) than observed. Our analysis suggests that antihypertensive therapy has had a significant impact on cardiovascular health outcomes but that mortality gains would have been approximately twice as high if guideline care had been achieved for all.

Here’s the link:

http://papers.nber.org/papers/W12096

New state-by-state fact sheets are now available at the Medicare Rx Education Network website.

Here’s the link:

http://www.medicarerxeducation.org/statefacts.htm

According to Canadian law enforcement authorities, the Hell’s Angels used their Canada-wide connections to supply a major drug trafficking network that operated in the lower Laurentians. Police seized 49 kilograms of cocaine and smaller quantities of hashish and marijuana. They also found more than 136,000 Viagra pills. Other people are still being sought on warrants in the on-going investigation, dubbed Project Piranha.

I’m blogging to you from the Arizona State University conference, “Transforming American Healthcare Over the Next Decade.” Organized by ASU, the C-Path Institute (led by CMPI board member Dr. Ray Woosley) and CMPI — this event brings together many of the leading thinkers on 21st century medicine.

Here are a few snippets:

The Second Hundred Years

“When you compare what’s available today versus 100 years ago you have to wonder whether we’re not spending enough on health care.” (Senator Jon Kyl, R, AZ)

T.S. Eliot and the Critical Path

“We must transcend mindless empiricism. Today medicine is still an empirical science. We still approach it as a one-size-fits-all situation. T.S. Eliot wrote that ‘Hell is the place where nothing connects.’ We must confront the unacceptable cost of an unconnected healthcare system.” (George Poste, MD, The Biodesign Institute, ASU)

Do not take this medication if you operate heavy machinery or are African-American

“The Critical Path will lead to advances such as gene or haplotype specific labeling as well as ethnopharmacology.” (George Poste, MD)

The Problem in a Snapshot

“Are today’s pharmaceuticals the Kodak film of the Digital Age?” (Ray Woosley, MD)

An Alliterative Illustration

“21st century medicine must be patient-centric, proactive, preventive, and predictive.” (Caroline Kovac, IBM)

And in case you don’t think regulators have a sense of humor

“Relative to polymorphic metabolism, slow metabolizers are cheap dates for their healthcare providers.” (Janet Woodcock, MD, FDA Deputy Commissioner and COO)

Well, so much for me-tooism. The ineffable LA Times, which actually does get things right occasionally, reports today the finding of a major government study “that at least a quarter of clinically depressed patients who failed to achieve a complete remission with one antidepressant succeeded by adding a drug or by switching drugs.”

Whoda thunk it? After all, did the Great Marcia Angell—-physician, economist, courageous siren with respect to The Truth About the Drug Companies—-not solemnly inform us awhile back that only two or three drugs in any given class are needed, and that further research and development investment in given classes is a social waste? And that the evil pharmaceutical producers are interested in profits and little else? And that advertising—-the provision of information—-is wasteful, and the the drug market simply does not work in some sense, ad infinitum? Well, yes, indeed she did. And indeed did she get virtually everything wrong in her silly book. Such are the fruits of economic analysis conducted by noneconomists with an ax to grind.

The LA Times published this latest report in the Science and Medicine section; Marcia’s “findings” were trumpeted on the front page, above the fold. But progress is to be welcomed.

I will be writing about this issue in far greater depth soon, but there seems to be a view in Beltwayland, among the suburbs of which are the NY Times and the LA Times, that drug prices ought in some sense to reflect “costs,” however defined, and that efforts by the pharmaceutical producers to establish prices for new drugs in accordance with their higher economic (or medical) value is illegitimate.

Well. Let us recognize that politics by its very nature is the art of wealth redistribution, always and everywhere, and so discussions of drug prices must proceed with that context firmly in mind. Drug development is a process of iterative investment, research, and testing; that process must appeal to the capital market (investors) in order to be viable, that is, expected returns (adjusted for risk) must justify the prospective costs of the development process for any given project. If prices reflect only costs and not value, investment streams will be reduced from levels that would prevail otherwise; and that means automatically that the future supply of new and improved medicines will be lower than in the alternative.

And so the preference for cost-based drug pricing on the part of those utterly compassionate with other people’s money in the end boils down to the argument that future patients ought to subsidize current ones. It is only a coincidence, of course, that it is the current patients who vote; thus does the wealth redistribution dynamic emerge yet again. And yet again the highminded compassion of the elites proves as phony as it is in so very many other contexts, except that a reduction in the supply of drugs means more future suffering and higher medical costs overall. Such are the outcomes yielded by the nostrums of the unthinking.

Apparently Consumers Union thinks that we should pay higher, not lower, hospital and doctor bills to prop up failing hospitals and subsidize charity care. At least that’s the rationale for the so-called consumer group which publishes price and quality ratings stereos and cars and supports price controls on prescription drugs for opposing the trend towards publishing the prices of doctor and hospital services. See healthgrades.com for examples. Bill Vaughn who publishes Consumer Reports, the ratings guides said that ” if enough patients choose less expensive hospitals, other facilities could have trouble caring for patients who cannot pay for services, which “would further break up the social safety net.” Or the more competitive hospitals would be able to care for more patients. Or perhaps the entire system would respond to consumer demand and begin to actuallly prevent disease before it starts rather than treat it after it happens using the newer medicines whose prices Consumer Union wants government to lower. In otherwords, Consumer Union wants government to limit the freedom of people to choose the best price for hospital and physician care and to drive down the price of new medicines artificially through price controls.

Ten years ago, few people predicted the impact of the Internet or the cell phone. Today the digital revolution has transformed the way we work, live and learn. Information is being turned into knowledge literally at the speed of light. Today, we are on the verge of another revolution that will dramatically change the way we live and how well we live.

So why aren’t people paying attention?

Over the next decade, researchers will use genomics to develop many more disease-specific drugs and diagnostics to predict who will respond best and who needs a medicine most than ever before. And medical information will be used to discover the best way to care for people based upon their unique genetic and individual circumstances.

So why doesn’t the media write about it more (or more enthusiastically)?

Drug, biotech and diagnostic firms are already gathering genetic information on patients taking part in clinical trials. New technological tools are currently available or under development that will help achieve this vision. The real concern, for industry and society alike, is not that technology will not advance, but that the technology itself will not be fully used.

So why isn’t government doing something to help FDA facilitate and advance the public health?

Last week the FDA announced the next phase of the Critical Path project — and in great detail. Unfortunately the announcement was largely ignored by the media, assorted thought-leaders, and our elected representatives.

We here at drugwonks.com will do our best to fill in the blanks, but we’d certainly appreciate some assistance from the MSM

Well, not really. But I did enjoy my 12 minute live segment on last night’s NewsHour with Jim Lehrer. Ray Suarez interviewed me and Dr. Alistair Wood on the future of the FDA. We talked about Andy von Eschenbach and Critical Path, and personalized medicine, and the fact that if we want the FDA to do more we need to make sure the agency is properly funded. And, yes, we also touched on Plan B.

Here’s a link to the audio archive: http://www.pbs.org/newshour/newshour_index.html

And here’s the video clip (“FDA Under Fire”): http://www.pbs.org/newshour/video/

Interesting article by Anna Mathews in today’s edition of the Wall Street Journal on how the FDA approaches the regulation of prescription drug product names.

Here’s a sample …

“The FDA’s scrutiny, an odd corner of the federal bureaucracy where language meets safety, is a growing problem for drug companies. They spend as much as $1 million per product making up, checking and registering words like Lipitor, Prozac and Zyprexa. In the 2004 fiscal year, the agency’s name-safety reviewers turned down 123, or 36%, of the proposed names they received. That was up from 90, or 29%, the year before, and 86, or 31%, in 2002. The rejection rate now may be even higher. The FDA recently toughened its procedure by requiring that possible names be checked against overseas brands because of concerns about U.S. drugs that have names identical to some used abroad, but very different uses.”

“To find out whether a drug works, a manufacturer runs studies, with the guidance of the FDA. The agency then decides whether the product merits approval. With a proposed name, the agency does its own internal tests to see whether the name is likely to be confused with that of an existing drug. The tests involve writing the names on mock prescriptions to check how they would look in real-world conditions, conducting Web searches and using a proprietary software program that the agency has never released.”

The full story (and it is worth reading) can be found at: http://online.wsj.com/article/SB114255589999700763.html