PDMSN - July 17, 2007 Full Issue

Vol. 1 No. 3

Pharma Behind in Online Advertising

It seems only yesterday that internet advertising was considered the wave of the future. Today, most major industries are riding that wave to a crest of profits. Although for some reason, though, the pharmaceutical industry isn’t one of them.

According to TNS Media Intelligence, a provider of strategic advertising intelligence to advertisers, ad agencies and media properties, companies spent $9.6 billion on internet advertising in the U.S. in 2006. In fact, internet ad spending was the fastest-growing category in advertising spending, increasing by 17.3 percent and accounting for 6.5 percent of all advertising funds compared with 5.8 percent in 2005.

Internet ads are no longer the domain of only startups or spammers — today, they’re used by Blue Chip companies like Walt Disney, Verizon and General Motors. In 2006, AT&T alonespent more on internet advertising — to the tune of $169 million — than the entire pharmaceutical industry did.

Numbers can be deceiving. It’s true that pharmaceutical web advertising increased by 9.5 percent between 2005 and 2006. But as a share of direct-to-consumer (DTC) advertising — which jumped 14.1 percent in 2006 in comparison with the overall market — only 3.5 percent of all DTC advertising was spent on internet advertising. In fact, relative to total DTC spending, the pharmaceutical industry is shelling out only slightly more than it did on web advertising in 2002. Not only that, the industry seems fully committed to “old line” media to reach consumers — case in point, DTC spending on print advertising increased by 24.7 percent in 2006. By comparison, in the industry world overall, magazine and newspaper ad revenues increased only 0.7 percent between 2005 and 2006.

Tangled Web of Reasons

Why aren’t pharmaceutical companies embracing web advertising the way other industries are?

For one thing, highly regulated industries tend to be more conservative, less flexible and less willing to take marketing risks than those with freer reign. That’s only natural with the number of real and potential lawsuits stemming from claims of misleading drug advertising.

All marketers have to penetrate a high level of “noise” — promotional activity by competitors of similar or other products — to reach their target audiences. But the problem goes beyond mere noise for pharmaceutical companies, which face added credibility issues simply because so many scam artists try to sell prescription drugs.

Another reason the industry may shy away from the internet is that the most common users of prescription drugs — that is, people age 65 and over — are the least likely to be regular internet users.  But that demographic may be changing. Most DTC efforts are in fact aimed at a slightly younger group — 50- to 64-year-olds — who are inclined to be both actively involved in managing their healthcare and heavy users of the internet. And by the way, these are the next generation of seniors. A national Kaiser Family Foundation survey of older Americans found that: more than two-thirds of 50- to 64-year-olds go online; more than half trust internet sources to provide some or a lot of accurate health information; and 24 percent of this age group gets “a lot” of health information online.

Hope on the Horizon

Pharma’s hesitance to advertise via the web made sense for a while given some of the factors outlined above. But as the technology has evolved, a number of new options have been introduced that could wash the old fears — and the rationale behind them — away.

As major websites have consolidated, it’s not necessary anymore to deal with lots of little websites to execute an ad campaign. And while most online ads were limited to display or banner ads and pop-ups a few years ago, the major sites now offer more sophisticated options such as targeted search advertising. According to the Internet Advertising Board, search advertising accounted for 40 percent of all internet advertising in 2006, versus 22 percent for display advertising.

There’s emerging evidence that search advertising works better than display ads for the pharmaceutical industry. A study by comScore Pharmaceutical Solutions found that 20 percent of consumers who became aware of a prescription product through the internet learned about it through search advertising, twice as many as those that discovered a drug through banner advertising.

Other internet advertising options are also becoming more attractive and effective. For example, rich media ads and access to high-speed internet have made the web a powerful advertising communication tool. And the level of technical quality and funding required to produce rich media ads — which combine animation, video and sound with interactive features — can help website users discern credible sponsors from scam artists who wouldn’t be able to afford such campaigns.

Setting Realistic Goals

Internet advertising alone isn’t likely to drive droves of patients to their doctors to request a specific prescription brand drug. Although what it can do at relatively low cost is guide patients to a manufacturer’s URL — where hopefully they’ll find clear, compelling and credible information about a pharmaceutical product. Used judiciously, internet advertising can help accomplish short-term DTC objectives, as well as longer-term benefits to patients, and another avenue to enhance compliance efforts. — Todd Clark

 

Future Bright for Medical Devices in China

China continues to move rapidly toward its long-anticipated position as a world economic power. In 2005, its gross domestic product surpassed that of both France and the UK, and the country now has the world’s fourth largest economy after the U.S., Japan and Germany. With double-digit growth rates expected for the near future, it is likely to move into the third place ranking within the next few years.

The medical device sector has been expanding at an even faster pace than the general economy. Investment analysts at Credit Suisse report 19 percent growth in 2003, 18 percent in 2004 and 17 percent for each of the last two years, bringing total device sales to slightly over $9 billion in 2006. Forecasts call for 16 percent growth in 2007 and 2008, which will result in $12.2 billion worth of sales in 2008.

In addition to this phenomenal growth, China is slowly but surely moving towards the regulatory practices seen in the developed world. Efforts to weed out corruption in the healthcare sector began in 2006 and have picked up pace since. After a trial lasting less than two weeks, the former head of China’s State Food & Drug Administration (SFDA) was sentenced to death in May for accepting bribes to approve drugs that led to more than a dozen fatalities. Last week that sentence was carried out. Two other top SFDA deputies were also charged, and one of these has been sentenced to 15 years in prison.

A number of other anti-corruption efforts are underway. For example, companies found guilty of bribery will be blacklisted from reimbursement lists and hospital bidding contacts for a period of two years. SFDA officials have been forced to divest holdings in drug and medical device companies. Also, in mid-2006, the Ministry of Health ordered all publicly owned hospitals to review their procurement policies and correct any improper activities.

These anti-corruption efforts should be welcomed by international devicemakers. In the past, due to the country’s size, political structure, degree of development and regulatory capabilities, there has been a wide discrepancy between official policies and market realities. Foreign companies have generally been in close compliance with laws and regulations. Among domestic producers and purchasers, however, bribery and backdoor deals have been common. Since buyers believe that foreign manufacturers have a considerable quality advantage over local firms, the crackdown may create a level playing field in device marketing benefiting foreign companies.

The country’s intellectual property legislative environment has also improved significantly in recent years, as the country moved to comply with the terms of its World Trade Organization membership. In 2006, Mike Barker, Chairman of the IP task force for European Chemical Industry Council (CEFIC), summed up the situation: “Chinese authorities have been doing a lot in the past three to four years to strengthen IP laws in China, and they have been actively protecting the business of some Western companies. ... Now you can go in and enforce patents in China.”

Geography, Quality are Keys

Given the improved outlook for doing business in China, what do devicemakers need to know about the market?

First, despite considerable progress, the healthcare system has a long way to go before it provides sufficient levels of healthcare for the majority of the country’s population. Seventy percent of the population lacked insurance at the end of 2006. The problem is particularly acute in rural areas and the disparity extends beyond health coverage to overall health spending. Per capita health spending in urban areas last year was $151, four times higher than the $37.70 spent in rural areas. To correct these problems, the government has launched a major investment program that will provide some level of coverage to nearly every citizen by 2010. Even if this ambitious goal is not met, the effort will be a major boon to the health sector.

This means that the medical device market is at present highly concentrated in the cities, particularly the large trading centers along China’s Pacific coast, although economic growth is starting to spread to cities in the country’s interior. As a result, there is a crowding out effect where foreign companies, with their more advanced and higher quality equipment, are dominating the major urban areas while domestic suppliers, faced with a changing business environment, are starting to concentrate on the less competitive mid-sized and small cities.

It is also worth noting that some of China’s leading device firms are starting to close the quality gap to the degree where they are able to compete head-to-head against international manufacturers. Thus, foreign companies will have to fight hard to hold on to the 60 percent share of market they currently enjoy.

Distribution Strategies

Hospitals are the overwhelming channel for healthcare delivery in China. Purchases for publicly owned hospitals at the county and higher levels must be made through a centralized tendering process, which was started as a pilot program in 2002 and has since been expanded nationally. Aside from cost containment, its purpose is to reduce the power of hospital administrators and change the misaligned incentives that led to misuse and overuse of equipment and drugs.

Under the program, hospitals and other institutions band together and request proposals from manufacturers. Agents, who are forbidden from having ties to the industry, handle negotiations. The winning bid becomes the price for purchases of that product by the institution, meaning that a secondary supplier would be required to meet the lower price in order to be included on the formulary. At the start of 2007, the bidding system was used by more than 80 percent of all Chinese hospitals. Within participating institutions, between 75 and 100 percent of purchases are made via tenders.

Direct distribution from manufacturers to customers was legalized in December 2004 as part of China’s WTO accession. However, due to the high number of manufacturer contacts that hospitals would have to manage and the lack of necessary logistical systems at the manufacturer level, the option is rarely used.

Instead, most companies rely on an extensive outsourced distribution and sales network. For example, Mindray Medical, which is a leading Chinese manufacturer of mass market devices, has over 1,800 distributors throughout the country. These partner firms generally take possession of the merchandise and assume the risk of selling it to customers. Approximately 60 percent of Mindray’s partners operate as the exclusive dealers within a particular geographic area. Distributors are also heavily involved in the tendering process.

For foreign manufacturers, the ability to tap into existing distribution networks certainly eases the process of entering the market. On the downside, with 20 percent average annual turnover, there is a high degree of instability with these arrangements. Also, the need to go through third parties can expose the manufacturer to liabilities if the distributor engages in unethical or illegal marketing practices.

In short, China still has a ways to go before its business practices match those of developed nations. However, with a market growing this fast and with signs of an improving business environment, now is the time is for any devicemaker that has not already entered the market to get off the fence and do so. — Todd Clark

 

FDA’s Preemption Doctrine Under Fire in Vioxx Case

In denying Merck’s motion for summary judgment claiming that two Vioxx product liability cases should be dismissed on federal preemption grounds, the U.S. District Court for the Eastern District of Louisiana Judge Eldon Fallon dealt a potential blow to pharmaceutical manufacturers that cite the FDA’s preemption doctrine in defense against state failure-to-warn liability lawsuits.

“The FDA’s current position on preemption represents a significant departure from well-settled administrative and judicial views on the issue, and ultimately is both unpersuasive and untenable in this multidistrict litigation,” Fallon said in his opinion.

The agency outlined its position on preemption in the preamble to the 2006 final rule: Requirements on Content and Format of Labeling for Human Prescription Drug and Biologic Products.

Fallon said because Congress did not explicitly state in the Food, Drug and Cosmetic Act that the law displaces state law claims with respect to pharmaceuticals, and because the agency’s views on preemption “were not promulgated pursuant to [the FDA’s] rulemaking authority, nor do they seek to clarify any ambiguity in the FDA regulations,” the preemption of state law should not be applied.

“The FDA’s preemption statements in the preamble actually conflictwith statements made in the original notice of proposed rulemaking out of which the 2006 final rule grew,” Fallon said. “At best, the preamble merely offers an opinion on the viability of the plaintiffs’ state-law claims given the existence of the federal regulatory scheme as a whole; it does not purport to interpret any specific statutory or regulatory provision, nor is it a regulation itself.”

According to Fallon, because there are no federal remedies for individuals harmed by prescription drugs, a finding of implied preemption in these cases would abolish state-law remedies and would, in effect, render legally impotent those who sustain injuries from defective prescription drugs.
 
Merck has been named in thousands of Vioxx (rofecoxib) lawsuits as an estimated 105 million prescriptions were dispensed to approximately 20 million patients between May 1999 and September 2004, according to court documents. The firm said it spent $121 million during the first quarter of 2007 on Vioxx-related litigation. — Christopher Hollis

 

Nevada Requires Marketing Code of Conduct For Pharmaceutical Companies

Nevada has adopted a new law that will require drug and device manufacturers to adopt  marketing codes of conduct to ensure sales practices benefit patients and do not inappropriately influence healthcare professionals.

The bill, which Gov. Jim Gibbons signed into law last month, requires any manufacturer or wholesaler that sells or markets a drug or device in Nevada to adopt a code of conduct establishing practices and standards for the marketing and sale of their products. The law goes into effect Oct. 1.

In addition to creating a code, companies must create a training program to educate all sales and marketing staff on the code and must conduct annual audits to monitor compliance, the law says. Companies must additionally have procedures for investigating noncompliance and designate an officer who will develop, operate and monitor the code.

The law also requires companies to report to the Nevada Board of Pharmacy annually about their codes of conduct, training programs, investigation policies, compliance officers and audits. 

Nevada’s law is similar to California’s drug marketing compliance law, which went into effect in 2005, according to Hyman, Phelps & McNamara’s Bryon Powell. However, Nevada’s law is less restrictive than California’s. For example, it does not require companies to include specific elements, such as limits on gifts to physicians, in the codes of conduct, Powell said. The Nevada law also does not require companies to post their codes of conduct on their websites, while the California law does.

The bill can be viewed at www.leg.state.nv.us/74th/Bills/AB/AB128_EN.pdf. — Emily Ethridge

 

HHS Projects Target Fraudulent DMEPOS Claims

Some manufacturers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) will have to reapply for participation in Medicare under new HHS projects to combat fraudulent DMEPOS claims.

HHS July 2 announced the details of the demonstration projects, which will take place in the Los Angeles and Miami areas over the next two years. DMEPOS manufacturers in these areas will need to reapply for participation in Medicare to maintain their billing privileges.

Letters will be sent out over the next three or four months to suppliers requesting that they resubmit applications, HHS said.

Those who fail to reapply within 30 days of receiving a letter; fail to report a change in ownership or address; or fail to report having owners, partners, directors or managing employees who have committed a felony within the past 10 years will have their billing privileges revoked. If successful, the projects could eventually be expanded nationwide, HHS added.

Miami and Los Angeles have been identified as “hotbeds” of fraudulent billing by DMEPOS suppliers. HHS, along with the Department of Justice, has formed a Medicare Fraud Strike Force to combat fraud through analysis of Medicare billing data.

Last December federal officials contracted with the National Supplier Clearinghouse to conduct visits to 1,472 South Florida DMEPOS suppliers, HHS said. After on-site investigations, 634 supplier billing numbers were revoked, saving Medicare an estimated $317 million, according to HHS. A similar initiative in the Los Angeles area last year resulted in 770 DMEPOS suppliers having their billing privileges revoked, the agency added.

American Association for Homecare CEO Tyler Wilson said he supports the projects, but added that it is important to “carefully separate fraud and abuse issues from Medicare policy decisions governing home medical equipment, services and therapies.”

Wilson previously co-authored a letter to Congress asking it to review Medicare’s processes for approving new durable medical equipment providers and auditing them after their supplier numbers are granted by the Centers for Medicare & Medicaid Services. Such systems “failed in Miami,” the letter said. — April Astor

 

Abbott Agrees to Cut HIV Drug Price in Brazil

The heat-stable version of the HIV drug Kaletra will now cost roughly 30 percent less in Brazil under an agreement signed by Abbott Laboratories and the country’s minister of health last week.

Kaletra (lopinavir/ritonavir) tablets will now cost approximately $1,000 per patient per year in Brazil, according to Abbott. The tablets, unlike the capsule form, offer the advantage of not needing to be stored at cold temperatures, according to the Ministry of Health. The ministry said it expects to save $11.4 million during the first year.

The tablets previously cost $1.04 each, but will now cost $0.73 through the end of the year. In 2008, each tablet will cost $0.68 under the agreement, the ministry said.

Brazil said it would begin distributing Kaletra tablets as part of its national HIV treatment program in September. The ministry estimates that 31,000 adult HIV patients will be taking Kaletra by the end of 2007.

“We wanted Brazil to benefit from the same price we offered to other countries with its level of economic development,” Heather Mason, Abbott’s vice president of Latin American operations, said. “The signing of this agreement symbolizes what can be achieved when governments and companies negotiate with the interests of patients in mind.”

Abbott announced in April that it planned to cut the price of Kaletra in 45 low- and low-middle-income countries. In countries in Africa and in least-developed countries elsewhere, the drug costs $500 per patient per year. “Tiered pricing is a key element in Abbott’s approach to ensuring broad access to its HIV medicines in the developing world,” the company said.

The capsule form of Kaletra is registered in 118 countries, Abbott said, adding that it plans to register Kaletra tablets in more than 150 countries total.
The Brazilian government had threatened compulsory licensing of Kaletra capsules in 2005, but after months of negotiations, Abbott agreed to lower the price by 47 percent to $0.63 per capsule.

Earlier this year Brazil attempted to negotiate reduced pricing for another HIV drug, Stocrin (efavirenz), but ended up issuing a compulsory license when Merck would not lower the cost sufficiently.

Thailand has also tried to barter for lower prices for several drugs, but ended up issuing compulsory licenses for Kaletra and Stocrin, as well as the heart drug Plavix (clopidogrel bisulfate). The move landed Thailand on the U.S. Trade Representative’s (USTR) 2007 Priority Watch List for intellectual property violations.

Several House lawmakers wrote to the USTR to request that Thailand be taken off the list, saying that it could threaten the country’s duty-free status for certain exports to the U.S. Indeed, the USTR announced late last month that both Thailand and Brazil have been removed from the administration’s Generalized System of Preferences program, which extends duty-free treatment to certain developing countries. — Breda Lund

 

Senator Working on National Gift Disclosure Registry for Physicians

Sen. Herb Kohl (D-Wis.) is working on a bill to create a national registry to disclose gifts physicians receive from the pharmaceutical industry, a spokeswoman said.
 
Staff members from the Senate Special Committee on Aging are working with other Senate staff and interested stakeholders to draft the legislation, although there is no timeline yet on the bill, the spokeswoman added. Kohl proposed the registry during a committee hearing last month.

Under the legislation, the disclosure registry would require physicians to report electronically all payments and gifts they received from pharmaceutical companies. The database format would require information on the type of payment or gift as well as the physician’s name.

The public would be able to access and search the registry. In addition, there would be penalties for failing to comply with the disclosure regulations, according to Kohl’s spokeswoman.

At the committee hearing, PhRMA Senior Assistant General Counsel Marjorie Powell said there would have to be much discussion before creating a national disclosure law so legislators understood the issue’s complexities. — Emily Ethridge

 

Patent Bill Amendment Addresses Post-Grant Review Provision

The Senate Judiciary Committee yesterday adopted an amendment that further tightens the language in the post-grant review and damages provisions of the Patent Reform Act of 2007. However, the committee stopped short of reporting the bill to the Senate floor.

Under a previous amendment adopted June 21, the post-grant review provision was revised so that a petitioner must have both a notice of infringement and proof of significant economic harm, instead of one or the other, to initiate the process. The provision would also not allow the same party to request multiple post-grant reviews of the same patent.

The Biotechnology Industry Organization (BIO) has said the review system could easily be abused and should be removed from the bill. “If a patent can be easily challenged at any time under a low standard of proof … patents will have much less value, and investment predicated upon them will inevitably be diminished,” Kathryn Biberstein, senior vice president of Alkermes, said while testifying on behalf of BIO at a committee hearing last month.

A broad industry coalition, which included BIO, sent a letter to House and Senate lawmakers June 19 requesting that the post-grant review provision be deleted. “Patent owners need more certainty — not less — that they can enforce their patents, invest and hire to expand their businesses and market their innovations free from unending harassment,” the letter said.

The latest amendment further narrows the criteria for initiating a post-grant review. “It tightens the post-grant review process to address concerns about abuse, while still ensuring that the system is sufficiently robust to provide an effective and efficient process for considering the validity of patents without the full-blown costs of litigation,” Chairman Patrick Leahy (D-Vt.) said.

To initiate a post-grant review, a petitioner would have to present a substantial new question of patentability to at least one claim. In addition, a party that has launched a district court action challenging the validity of the patent cannot also file for post-grant review. And during the so-called second window, or the period of time after a year of patent issuance, a petitioner must file for review within a year of receiving notice of infringement.

The amendment also clarifies the damages provision, further explaining how a court should calculate the value of reasonable royalties. BIO and other industry groups had additionally requested that the damages provision be deleted from the legislation, saying it would promote more frivolous litigation.

“I respect the constructive concerns that were raised about how the language of the current bill would affect the value of combination patents and how ‘reasonable royalty’ is defined,” Leahy said. “The amendment accommodates these concerns, while retaining the core principle of the provision.”

Leahy said he hopes the committee will vote on the legislation soon, so that the bill reaches the Senate floor this fall. Sens. Dianne Feinstein (D-Calif.) and Jon Kyl (R-Ariz.), however, said the committee needs more time.

“I believe there are a number of unreconciled issues,” Feinstein said, noting that the biotechnology industry is still unwilling to accept the post-grant review and damages provisions.

Kyl said he finds it unlikely that juries would be able to accurately calculate the value of prior art when proportioning reasonable royalties. “This is an extremely complicated subject,” he said. “This damages issue is central to the entire bill.” — Breda Lund

 

Tips of the Week

Pharma:

  • Pharma 2020, a new report from PricewaterhouseCoopers (PWC) underscores the rising importance of the bigger developing countries. The so-called E7 Group, which consists of Brazil, China, India, Indonesia, Mexico, Russia and Turkey, is expected to see a tripling of real gross domestic product by 2020 with the result that the share of world pharmaceutical sales represented by these countries will rise from 8 percent currently to 20 percent. Separately, IMS predicts that China will be world’s fifth largest market and that Turkey will move into the top ten by 2010. Given the stagnant growth rates in Europe, Japan and, to a lesser extent, even the U.S., pharmaceutical companies would do well to devote attention to these up and coming markets. A copy of Pharma 2020 may be downloaded from the PWC’s website at: www.pwc.com/extweb/pwcpublications.nsf/docid/91BF330647FFA402852572F2005ECC22.
  • Pharmaceutical marketers are facing an increasingly adverse environment in the northeastern tip of the U.S. On June 29, Maine joined neighbors New Hampshire and Vermont in attempting restricting commercial use of data identifiable at the prescriber level. New Hampshire’s law, the first of its kind, was overturned by a federal judge in late April. The state is appealing. However, the ruling seems to have done more to provide a blueprint for creating statutes that will pass constitutional muster than to stem the data restriction tide. Like Vermont, Maine addressed many of the flaws cited in the New Hampshire case. Maine’s law was signed on June 29th 2007 and is effective January 1st 2008. A copy may be found at janus.state.me.us/legis/LawMakerWeb/externalsiteframe.asp?ID=280022219&LD=4&Type=1&SessionID=7

Devices:

  • The 2007 meeting of the American Diabetes Association (ADA) was “relatively quiet from a device perspective” according to the June 25 Bear Stearns analyst report, “ADA 2007: Interest in Continuous Glucose Monitoring Still High.” However, there was one major area of excitement: continuous glucose monitors (CGM). Ever since the 1993 Diabetes Control and Complications Trial, tight glucose control has been the primary objective in diabetes therapy. As with most new technologies, reimbursement issues are a big stumbling block to adoption. It is likely that the Centers for Medicare & Medicaid Services and private payers will hold off on subsidizing the devices until the results of several big trials are in, probably several years in the future. In the meantime, manufacturers should consider some form of direct-to-consumer marketing. A product with easily demonstrated benefits for a large patient population would do well by going straight to the end-user.
  • The European Union (EU) Delegation of the European Commission (EC) to the U.S. said the EC and the FDA agreed to confidentiality arrangements that will allow the two to exchange confidential information about the safety of medical devices. The types of information covered in the new confidentiality arrangements include: advance drafts of legislation and/or regulatory guidance documents; postmarketing data and information that could have an impact on public health, such as vigilance data or information about impending regulatory actions; and information on ongoing and emerging regulatory issues of health and safety in the U.S. or the EU.

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Reporters: Martin Gidron, Emily Ethridge, April Astor, Breda Lund, Christopher Hollis

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