A Ray of Sunshine?

It’s already 15 months overdue and it will be another year still before the information is public, but last week  the government  set out  the final rule for the Physician Payment Sunshine Act (Sunshine Act) in a 287 page document!

The Sunshine Act (passed in 2010 as part of the Affordable Care Act) requires manufacturers of drugs, devices, biologicals, and medical supplies to report all payments and other transfers of value to physicians and teaching hospitals. The rule was supposed to be published in October 2011, but has suffered continuous delays amongst intense lobbying both by groups keen to get the data in the public hands, such as the AARP, and those most affected by it, such as the American Medical Association (AMA).

The final rule announced February 1^st, officially puts the Industry on notice. They have until March 2014 to get their payments reporting act together. The U.S. Centers for Medicare and Medicaid Services (CMS), will then input the data, including payment information from August through December of this year, into a publicly available database which, they say, will be online by September 2014.

And its not only payments to doctors of medicine that have to be reported. Under the definitions of the Act, “physicians” include doctors of osteopathy, dentists, podiatrists, optometrists and chiropractors.

The rule also requires reporting on both the form and nature of payment or transfer of value made by a manufacturer to a physician.

Forms of payment included under the final rule :

• Cash or a cash equivalent
• In-kind items or services
• Stock, a stock option, or any other ownership interest, dividend, profit or other return on investment
• Any other form of payment or transfer of value

While, nature of payments include:

• Consulting fees
• Compensation for services other than Consulting
• Honoraria
• Gifts
• Entertainment
• Food
• Travel
• Education
• Research
• Charitable contributions
• Royalty or license
• Current or prospective ownership or investment interest
• Direct compensation for serving as faculty or as a Speaker for a medical education program
• Grants
• Any other payment

Advocates of the Sunshine Act have long argued that the public needs to know when doctors are getting paid and by who. “You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need,” said Peter Budetti, M.D. CMS deputy administrator for Program Integrity. “Disclosure of these relationships allows patients to have more informed discussions with their doctors.”

This increased transparency is also intended to help reduce the potential for conflicts of interest that physicians or teaching hospitals could face as a result of their relationships with manufacturers.

Relationships between doctors and drugmakers have been brought up in a number of cases when FDA advisory panels have ruled for or against drugs in which doctors had some interest. For example, last year an advisory panel voted 15-11 to support the approval of Bayer‘s Yaz birth control pills, but allegations later surfaced that four committee members had ties to the manufacturer.

Once the bill is introduced, doctors will get 45 days after information is submitted to vet it for accuracy.

The American Medical Association (AMA) is not happy.  The doctors’ group wants physicians to have more than 45 days to challenge information in the government’s database and add commentary to explain the payments. It also wants some corporate contributions to physicians excluded from disclosure, including sponsorships for educational activities and “indirect” payments, such as unsolicited contributions a company might make to a nonprofit group affiliated with doctors or to physicians’ employers or practices.

AMA president Jeremy Lazarus wants to ensure “the registries will provide a meaningful and accurate picture of physician-industry interactions. It is critical that the final rule provide physicians with a clear way to correct any inaccurate information and not place any substantial administrative burden on physician practices.”

And the AMA is not alone. Unsurprisingly, the Pharmaceutical Research and Manufacturers of America (PhRMA), the primary lobbying group for drugmakers, said that while it supports more disclosure, the new regulations should take into account the importance of context in the publication of physician payment information.

“Ethical interactions between biopharmaceutical companies and health-care professionals are essential to maintaining patient trust,” said Matthew Bennett, a spokesman for PhRMA. The principle behind the so-called sunshine provision “is complementary to this belief and it has great potential for helping patients understand the ways in which such collaboration benefits their health and medical innovation,”

What’s your take on this new rule? Is the government helping to let the sun shine in or is this a dark, dark day for doctors and pharma?  Let us know your thoughts.

FDA Ad Study: Clarifying the Confusion

As a public health agency, the FDA encourages the communication of accurate health messages about medical conditions and treatment.  One way the pharma industry does this is through non-branded disease awareness communications. These are aimed at either the general public or health care practitioners and discuss a particular disease or health condition, without making mention of any specific drug.  Usually, they encourage consumers to seek, and health care practitioners to provide, appropriate treatment for the particular disease state.

This is helpful for under-diagnosed and under-treated diseases such as depression, hyperlipidemia, hypertension, osteoporosis, and diabetes. Some research has shown that consumers prefer disease awareness advertising. It’s considered more informative and less persuasive than full product advertising.

The pharma industry likes it too.  Disease awareness communications are not subject to the regulations and restrictions mandated by the FDA for prescription drug advertising.

But now, the FDA is concerned that disease awareness ads might confuse consumers. According to a Federal Register notice issued on June 20, the agency wants to know whether the public can distinguish between product claims and disease information, and how different types of information impact comprehension.

So worried in fact,  the Agency has planned a study entitled, “Experimental Study: Disease Information in Branded Promotional Material” to look into those questions.

The study will examine print ads for three conditions – COPD, lymphoma and anemia.

4,650 American adults will be divided into three groups and asked to review the ads electronically.

• One group will see information about the disease that avoids discussion of disease outcomes the drug has not been shown to address i.e.  “Diabetes is a disease in which blood sugar can vary uncontrollably, leading to uncomfortable episodes of high or low blood sugar.”
• Other participants will see disease information that mentions consequences of the disease that go beyond the indication of the advertised product, such as, “Untreated diabetes can lead to blindness, amputation, and, in some cases, death.”
• A third group will see drug product information only.

Disease information will be presented in different ways. For example, on alternating paragraphs, on separate pages or in different fonts and colors from product claims.

Specifically the study will address whether or not consumers are able to distinguish between claims made for a medication and general disease information when they see an advertisement for a drug.  For example, if an ad for a drug that lowers blood glucose, mentions diabetic retinopathy do consumers  think the drug will prevent the affliction, even if no direct claim is made?

The Agency says: “If consumers are able to distinguish between disease information and product claims in an ad, then they will not be misled by the inclusion of disease information in a branded ad. If consumers are unable to distinguish these two, however, then consumers may be misled into believing that a particular drug is effective against long-term consequences.”

SRxA’s Word on Health looks forward to seeing the results. Given that warning letters have been issued in the past over ads that contain mixed messages, this is an opportunity for the FDA to revisit its stance toward such advertising, reduce consumer confusion and, most importantly, learn how best to disseminate useful health information.

A Record Year for the FDA

Regulators have taken much of the blame for the drug industry’s monumental problems, especially their inability to bring new products to market, leaving the US lagging behind many other countries. Now the FDA is fighting back.  The Agency just announced that it green-lighted 30 new drugs in 2011 – a 7-year high.  Among these, Johnson & Johnson  and GlaxoSmithKline received approval for three new drugs each.  FDA Commissioner Margaret Hamburg also noted that it had been the first regulatory authority worldwide to give the nod to a number of novel treatments including  as Seattle Genetics lymphoma drug Adcetris. One possible reason for the increase in new drug approvals was the Agency’s willingness to meet with pharmaceutical companies before data were submitted.  Another may be the industry’s focus on submitting better data, particularly in regard to drug safety.  “I think people have realized that FDA has gotten more difficult and they’re improving what they turn in,” says Citigroup analyst Yaron Werber. Even so, the pharma industry is expecting some tough years ahead with increased generic competition for many of the top-selling drugs. And it remains to be seen whether the industry and the FDA can stay with the 2011 pace for approvals or whether they will sink back to the low numbers experienced in years past.

Treading Lightly – A New Approach for Pharma

Last week, the Wall Street Journal reported on a dramatic change occurring in the pharmaceutical industry. The on-line article explored how many of the big pharma companies are changing their commercial model in response to the current economic and regulatory conditions. Most notably, drug reps are being encouraged to soften their sales pitches and re-position themselves as a trusted resource for the doctors they call upon. British drug giant GlaxoSmithKline (GSK) for example, has stopped evaluating salespeople based on the number of prescriptions written  Instead, they look at how well physicians rate their representatives. GSK, Merck and Lilly are also asking their representatives to switch from making forceful, tightly scripted sales pitches to acting more like a resource supporting physicians’ treatment. Companies hope to get a foot in the door by providing practical help, such as assistance educating patients about their diseases or navigating reimbursement. Why now?  Clearly, prescribers, who are under increasing pressure from health plans to curb costs, have less time for, and patience with, persistent sales representatives. Plus, the government has been cracking down on aggressive, and off-label marketing. For some, myself included, this is nothing new. Almost 20 years ago when I worked in pharma, I rarely “detailed” my products. Instead, I helped “my doctors” build websites for their own practices, helped to organize, and on occasions even moderate, their clinical meetings and assisted them with….well just about anything they wanted assistance with, be it product related or not. The strategy worked, sales grew and my competitors, even those with better products or prices were neutralized. “Increasing physician satisfaction, it turns out, is a much better way to promote a pharmaceutical agent than simply telling them to write more prescriptions or what the benefits are,” says David Ricks, president of Lilly’s global business unit. Unfortunately, salespeople still can’t provide the one thing many doctors want above all – time!  Even though pharmaceutical companies are attempting to engage prescribers in a more pleasant way, they still don’t always get a positive reception because nothing is being done to solve the doctors’ time problem. The bottom line is that physicians need to fit more patients – not sales reps – into their workday. Although it’s estimated that pharma sales reps  pay 115 million visits to 340,000 doctors each year, 23% of doctors surveyed by market research firm SK&A in 2010 said they don’t see drug reps at all. Eli Lilly decided to adopt its new approach after watching launches of new drugs fail. One problem the company identified was a mismatch between what doctors expected based on sales pitches, and what the products delivered. Before the change in tactics, psychiatrist Carey Cottle, MD says he was more likely to write prescriptions for a competing antidepressant like Pfizer’s  Effexor over Cymbalta, because Lilly representatives had a “high-pressure, car sales-type approach, and it was just not appropriate.” Now, surveys of doctors show that 85% are satisfied with Lilly, up from the 60% before the company changed ways. And business is up too. Sales of Cymbalta were >$450 million higher during the first nine months of 2011, than during the same period in 2010. We’d love to hear what doctors and sales reps think about this.

A Big “Clap” for the FDA

Sexually transmitted diseases (STDs) have always been a bit of a taboo subject.  Especially it seems among the FDA.   In a joint initiative with the Federal Trade Commission (FTC), the Agency has just sent warning letters to more than a dozen companies selling non-prescription products that claim to treat STD’s such as herpes, chlamydia, genital warts, HIV, and AIDS.

Despite names such as Medavir, Herpaflor, Never An Outbreak and C-Cure, the FDA says that none of the products have been proven to prevent, treat or cure any disease.  In fact, say FDA scientists, the products are a public health hazard because patients could waste time taking them and delay seeking medical care.

A full list of the companies and products involved can be found here.

These products, sold both online and in retail outlets, often claim to be supported by research. A website for Medavir, made claims the product “has been proven effective in several official university research studies, including an official FDA trial.”

Similarly, Arenvy Laboratories’ website for ImmuneGlory touts the product as “the ultimate herpes outbreak solution” and claims the product “strengthens your immune system so that herpes or cold sores have nowhere to hide.”

However, the Agency says that is has never approved any non-prescription products for sexually transmitted diseases.  Drugs are available for herpes, chlamydia, HIV and other diseases, but only via prescription.

“These products are dangerous because they are targeted to patients with serious conditions, where treatment options proven to be safe and effective are available,” said Deborah Autor, FDA Director of Drug Compliance.

Companies cited by the FDA will have 15 days to take their products off the market. If they do not, the agency can take legal action, including seizing products and taking company officials to court.

Additionally, under the FTC Act it is illegal to make such unsubstantiated treatment claims.

“These companies are on notice that advertising health benefits that are not supported by rigorous scientific evidence violates the FTC Act,” said David Vladeck, Director of the FTC’s Bureau of Consumer Protection. “They also should know that health scams that endanger public health will not be tolerated.”

While we wait with baited breath to see if the companies will comply, Word on Health cautions its readers that appropriate treatment of STDs can only occur under the supervision of a health care professional.

FTC to take a pop at pop-ups?

Who among us hasn’t searched the Internet for information on asthma, allergy, or just about any other disease only to be plagued by unwanted  pop-up ads for drugs for that condition?

You’re not alone.   However, consumer and privacy groups are now asking the Federal Trade Commission, (FTC), to investigate and crack down on this allegedly “deceptive and unfair” marketing of drugs and dietary supplements on health-advice websites and forums.

The groups, including the U.S. Public Interest Research Group, the World Privacy Forum and Consumer Watchdog, filed a complaint with the FTC in November charging that pharmaceutical companies and the medical industry are secretly gathering information about patients, their conditions and their drug and treatment preferences through health websites, e-newsletters and online drug coupons.

The advocacy groups charge that when consumers use interactive health websites and social media to search for information on specific diseases or conditions, they’re often bombarded with ads for costly brand-name drugs and steered away from less-expensive generics and over-the counter medications. Some of the websites also fail to differentiate between objective editorial content and advertising, the groups say.

They also charge that some websites are spying on consumers, monitoring social media and using “cookies” and other means to track computer users’ habits in order to build personal profiles. The organizations say online health and medical marketers spent nearly $1 billion in 2010 targeting online consumers.

Privacy advocates are concerned that some of the marketing information gathered by companies could be used against consumers later — for example, by life insurers or employers to deny policies or employment.

Online advertisers generally contend the information they collect is anonymous. But privacy groups say a name isn’t necessary to identify someone, and consumers should be required to give consent to having their personal information collected.

Congress is currently considering measures that would strengthen online privacy protections, including “Do Not Track Me” legislation that would allow consumers to block computer technology that companies use to track their online behavior.

Meanwhile, SRxA’s Word on Health advises its readers to be skeptical of believing all  they see and read online.  While some condition-specific electronic health newsletters and discount coupons can be genuine and extremely informative, there are many other companies advertising products that may be counterfeit or just a scam.

As always, we suggest you discuss new therapies with your doctor before trying them so see if they are right for you. Additionally, don’t forget to read the small-print and privacy-policy disclosures before giving personal health information to online vendors.

Want to weigh in on this discussion.  We’d love to hear from you.

New Perspective on Pharma- Physician interaction

Despite ever increasing regulations, and even though some institutions and medical societies have adopted policies that limit or ban such practices, new research shows that most physicians and doctors-in-training still have a positive attitude toward the marketing activities of pharmaceutical companies.

According to the study published in the June Archives of Surgery 72% of surveyed doctors and medical students said sponsored lunches were appropriate. Nearly 60% said samples improve care for their patients, and 71% said pharmaceutical and device company money is useful for funding residency programs.

Additionally, the majority of doctors thought that educational material supplied by pharma (68.8%) and device (78.5%) companies was a useful way to learn about new products.

There were limits, though. About 3:4 respondents believed gifts valuing more than $50 were unacceptable and almost all thought vacations were inappropriate.

The study authors polled almost 600 faculty and medical trainees at 11 New York City hospitals that have banned or limited the interaction between physicians and industry.

Some difference was seen between different physician groups. Surgeons were more likely to have a positive attitude toward industry. They believed that gifts, such as residency funding and travel reimbursement for attending lectures, are acceptable. Pediatricians held less favorable attitudes.

Interestingly, 73.2% of physicians thought that their institution should allow physician-pharma interaction while almost the same number (72.7%) strongly believe that their prescribing was not influenced by industry marketing practices.

Clearly, not all physician-industry interactions are created equal. While politicians and regulators would have physicians shun all contact with the pharmaceutical and device industries, many doctors believe such relationships are healthy and beneficial.

Before regulators rushed to reduce conflict-of-interest, maybe they should have talked to the very people most impacted by the rules.  Word on Health is not surprised that doctors take umbrage at the suggestion that a pen or a sandwich paid for by industry might affect their judgment. The public demonization of financial relationships between physicians and industry, although widespread, is not supported by any conclusive evidence.

Despite this, relationships continue to be investigated and regulations become more rigorous. Are they too much or too little?  We’d love to hear your views on this. Please leave a comment below.

FDA launches BadAd campaign

Stethoscope? Check. White Coat? Check. Whistle? Pardon!!!

Citing a limited ability to identify violative pharmaceutical advertising and promotional activities, the FDA has announced the launch of its “Bad Ad” Program.  The Program encourages health care prescribers to directly report false and / or misleading drug advertising, marketing materials and promotional activities to the FDA – specifically activities that:

• omit or downplay the risks of a drug
• overstate the effectiveness of a drug
• promote off-label uses
• compare drugs in a misleading manner

In addition  to asking doctors to whistle-blow on violations that occur during speaker programs, sales presentations, TV, radio & print advertisements, websites and print materials the FDA wants doctors to “monitor promotional activities that occur in private.”

FDA is particularly interested in what pharma reps say during sales calls, presentations, discussions at medical conferences, and in other face-to-face interactions.

Health care professionals who encounter suspect claims or activities are asked to notify the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC). As part of the program, the FDA will offer physicians training at medical conferences on how to identify misleading sales aides. In addition, the agency has simplified the reporting process which now includes a hotline and email address.  Submissions may be anonymous.

DDMAC enforcement activity has  risen dramatically over the past year, and the “Bad Ad” Program suggests that FDA hopes to take even more enforcement action in the future.  The issue of concern here is whether by directly engaging the help of doctors as informal enforcement agents, the FDA is creating an “us against them” culture – where “us” is FDA and doctors, and “them” is the pharmaceutical industry.

While Word on Health is all for marketing compliance we wonder if doctors will  answer the call.   Do they have the time to be on the  look-out for bad ads?  Will they want to engage in time consuming activities for which there is no reimbursement? And do they want to be seen as the “enforcers?”

But assuming they will, SRxA can help guide you through the complex world of marketing compliance. We can help you deliver non-violative information to physicians. Contact us today for more information.