They’ve also overlooked a lot of the positive aspects of the project. Deen will be offering diabetes-friendly recipes that do not comprise taste and appearing at diabetes cooking events across the US. The initiative is called Diabetes in a New Light.

But if you’re familiar with Deen’s cooking, you’ll be aware that a lot of her dishes are not exactly promotional of a healthy diet (examples include bacon cheeseburger meatloaf and southern fried chicken – you can take a look at the recipes on her website), which is where media criticism has been directed. Deen herself was also diagnosed with Type II diabetes three years ago, but only revealed this to the public this week, another aspect that has attracted criticism since she’s maintained her cooking style, despite the fact that diet is an important part of managing diabetes.

However, Deen makes a good point of saying in a press statement that “diabetes does not have to stop you from enjoying the things you love”.

At a time when obesity is rising, it’s important for us to be aware of healthy food, and chefs need to take some responsibility. Let’s be honest though, most of us don’t want to be healthy all the time, so we want to know how to make the best of our butter!

In their criticism, a lot of news sources have overlooked the contributions Deen is making to the diabetes battle. She claims to have made small dietary changes and to have worked more exercise into her day. Being a celebrity spokesperson for diabetes will also be a good influence – some sources have made snide comments about the connection between Deen’s weight, her recipes and diabetes, which will no doubt influence some people into avoiding unhealthy foods.

And with all the attention being focused on the responsibility of celebrities and chefs to promote healthy eating, Novo Nordisk and the pharmaceutical industry has gotten a bit lost. The pharma industry also has a responsibility to promote good health; indeed, this focus is becoming increasingly important in pharmaceutical business strategies as non-traditional companies, such as food and IT companies, muscle into the healthcare sector. Ernst and Young has a really good report about this trend available on their website.

Even though the diabetes campaign is partly to promote Novo Nordisk’s diabetes drug, Victoza, it’s also a step towards health education. According to one news report, many diabetes patients have trouble managing their diet. Havilah Clarke, senior manager, product communications at Novo Nordisk is quoted in the report as saying, “Based on what were hearing from some primary research we were doing, people living with diabetes thought that food was one of the most difficult challenges to address in their social lives. They thought they had to deprive themselves.”

Whatever Novo Nordisk’s intentions, it remains to be seen whether using Paula Deen will be a successful strategy given the amount of criticism the partnership has received. But there’s no such thing as bad publicity, right?

Proposed spending cuts targeted at healthcare programs, such as Medicare and Medicaid, certainly will have an impact on healthcare providers and the healthcare system. Of particular concern for the pharmaceutical industry are proposed spending cuts in the prescription-drug benefit under Medicare Part D.

“It is extremely unfortunate that President Obama continues to push for a policy that could destabilize the successful Medicare Part D program and have a devastating effect on American jobs,” said Pharmaceutical Research and Manufacturers of America (PhRMA) Vice President Karl Uhlendor, in a PhRMA statement. “Government-imposed price controls in Part D could fundamentally alter the competitive nature of the program and threaten its success. Savings achieved in Part D are passed onto beneficiaries, contributing to the program’s success in holding costs far below projections, while achieving very high marks from seniors.”

PhRMA points to a recent PhRMA-funded report by the IMS Institute for Healthcare Informatics, which showed that on average costs for medicines in the top 10 therapeutic classes in Part D declined by more than a third between January 2006 and December 2010, from $1.50 to $1.00. IMS Institute projects that costs will continue to decline, reaching $0.65 by the end of 2015, representing a 57% decrease from 2006.

Also weighing in on the debate is the healthcare policy think tank, the Kaiser Foundation, which provided an updated side-by-side summary of changes to key Medicare provisions found in five major debt-reduction plans put forward by the White House, Congress, and independent, bipartisan commissions. The five plans, which were put forth at various times between Nov. 17, 2010 and July 19, 2011, are: the President’s Framework for Shared Prosperity and Shared Fiscal Responsibility; the House Concurrent Budget Resolution; the Senate “Gang of Six” Proposal; the National Commission on Fiscal Responsibility and Reform (Bowles-Simpson); and the Bipartisan Policy Center Debt Reduction Task Force (Domenici-Rivlin).

Whether these debt-reduction packages or others emerging from this week’s debate will make it through Congress in response to the pending debt-ceiling crisis is anyone’s guess at this point, but what is clear is that fiscal reform and its related impact on healthcare spending and drug-reimbursement levels will certainly affect the pharmaceutical industry. Whether the battle is here in the United States or abroad, national healthcare and drug-reimbursement policies affect the pharmaceutical industry.

Perhaps more important than short-term pricing effects, however, are potential influences on drug development. “Building a better mousetrap” is no longer a sufficient paradigm in drug innovation, which has to factor in the cost, pricing, and potential reimbursement of a drug. In tighter healthcare-spending environments, for example, will a new, more expensive drug for hypertension be reimbursed when an older, off-patent drug may be considered sufficient? How novel will a new drug have to be in order to be reimbursed by national governments or private insurers, and will it be worth the drug-development dollars to see? Does such an approach encourage a more sustainable healthcare environment or not? There are no easy answers for these questions, but what is clear is that drug reimbursement has become an important ingredient in drug development and commercialization.

See related blogs, “Could US Budget Woes Undo HIV Breakthroughs?”

One of the plaintiffs, Natalie Celske, received several awards for her performance as a sales representative, according to the complaint. She became a district trainer and expressed interest in being promoted. Celske’s manager, however, removed her from her role as a trainer and replaced her with Celske’s male colleague James Webb, even though his performance had not been as good as hers. When Celske asked her manager why he had removed her from her position as trainer, he allegedly replied that the job was “more into James’s career path, not yours.”

Another employee, Vera Santangelo, alleged that a male senior employee sexually harassed her repeatedly. On several occasions, he grabbed her and made comments about her body. Distraught, Ms. Santangelo reported the harassment to the company hotline and to an ombudsman, but the senior employee’s behavior continued and a manager dismissed or diminished her complaints.

In an October 2010 internal newsletter, the company suggested that men are better suited for management positions because “the fairer sex” is prone to “mood swings,” “indecision,” and “backstabbing.” One of the company’s vice-presidents allegedly announced that he was “never hiring another woman over 40 again. They’re all crazy!” When women have complained about these attitudes, the company’s human resources department often responded with comments such as, “this is just the way it is, deal with it,” according to the complaint.

Bayer’s employees’ allegations deserve a full and fair airing. Coming in the wake of similar, and successful, suits against Novartis and Sanofi, the class action against Bayer indicates that the pharmaceutical industry as a whole should evaluate its policies toward women. Women have demonstrated their dedication and talent time and again, and research has shown the advantages that women bring to any company. It’s well past time for us to shed whatever remaining vestiges of sexism we may have.

Bayer is accused of paying competitors such as Barr Laboratories and Watson Pharmaceuticals in the 1990s not to market generic versions of Cipro, an antibiotic, for six years. The agreement allegedly saved Bayer $1 billion in Cipro sales. Recently, a group including large drug wholesalers, pharmacies, unions, and healthcare plans filed an antitrust lawsuit against Bayer and the companies with which it entered this pay-for-delay agreement. These groups, some of which are public entities, purchased Cipro directly and could have saved money if they had been able to buy generic versions of the drug at a lower price.

California Attorney General Kamala D. Harris and 31 other attorneys general signed an amicus brief in support of the plaintiffs, urging the Supreme Court to review pay-for-delay agreements. The brief argues that the deals violate the Hatch–Waxman Act because they discourage the speedy entry of generic competition. The attorneys general also claim that holding a patent on a drug does not grant a company the right to collude with competitors or to pay them not to compete.

A “surge” of these agreements is undermining generic competition and forcing states and consumers to “pay monopolistic prices for branded drugs,” says the brief. Studies by the FTC suggest that the deals cost consumers anywhere between $3.5 and $14 billion each year, the attorneys general argue.

In the absence of robust pipelines bursting with new blockbusters, it’s easy to understand why an innovator company would want to forestall competition (and preserve profits) for as long as possible. But I think that a company that cherishes the free market cannot enter into such agreements in good faith.

We’ve been hearing that the blockbuster model will soon be a thing of the past. Companies such as sanofi-aventis are trying to think ahead by focusing on emerging markets, smaller patient groups, and, yes, even generic drugs. This kind of plan might well sustain drug companies in the absence of blockbusters and, if it works well enough, could help fund the discovery and development of needed new therapies.

If the Supreme Court eventually invalidates pay-for-delay agreements, the pharmaceutical industry should not mourn them. Alternative strategies are already pointing out possible paths to prosperity. I think the industry would be wise to follow sanofi’s example and not to fear competition.

First, the Act will mean an increase in drugmakers’ sales, according to a PriceWaterhouseCoopers (PWC) report. About 32 million additional people will be insured by 2019, and about half of them will be covered by Medicaid. The insured are more likely to fill prescriptions, so this is to the industry’s benefit. But the Act will also raise the rebates required of branded-drug manufacturers from 15.1% to 23.1%. Will this hurt drugmakers? Probably not. “The impact of an increase in the Medicaid rebate rate may be less extensive than believed as rebates currently in place already exceed this rate,” says the PWC report.

Previously, pharmaceutical companies often lost sales when beneficiaries entered the doughnut hole in Medicare coverage. But the Act contains several provisions to help patients move through the hole quickly. As of the Act’s signing, the government will pay a $250 rebate to each patient in the hole. By 2011, manufacturers will have to provide 50% discounts on branded drugs to patients in the doughnut hole. Although this might sound bad, the PWC report notes that drugmakers already provide discounts on prescriptions filled in the coverage gap. So this part of the Act might not affect drugmakers much, except perhaps by boosting sales.

On the other hand, the Act requires each pharmaceutical manufacturer to pay a fee based on its share of total branded-drug sales to government programs. Executives told of this detail might have responded, “I knew there was a down side.” Not so fast. The Act divides sales amounts into five ranges and taxes each range at a different percentage. A company with $300 million in sales would pay nothing on its first $5 million, 10% on sales between $5 and $125 million, 40% on sales between $125 million and $225 million, and 75% on sales between $225 million and $300 million. “Given the fixed dollar amount, over time, the impact diminishes relative to pharmaceutical sales,” said the PWC report.

Finally, large biopharmaceutical companies knew right away that healthcare reform would be good for them because the Act gives innovators 12 years of data exclusivity. Many small biopharmaceutical companies and manufacturers of generic biologics likely felt left out when they heard the news, but there’s a silver lining. The Act allocates $1 billion for a two-year temporary tax credit to encourage the development of new therapies. The 50% tax credit will go to companies with 250 employees or fewer, and is intended to help small, undercapitalized biotech companies, according to the PWC report.

At worst, healthcare reform will likely have little effect on drugmakers’ pocketbooks. At best, it will increase their sales without greatly increasing the amount of tax or rebates they pay. Pharmaceutical executives may soon be moved to paraphrase Patrick Henry and say, “If this be socialism, make the most of it.”

The Justice Department charged that AstraZeneca improperly influenced the content of continuing medical-education programs that it sponsored so that it could promote unapproved uses of Seroquel. The US also alleged that, in an attempt to influence physicians’ prescribing habits, AstraZeneca paid doctors to give promotional lectures to other healthcare professionals about unapproved uses of Seroquel. Such payments violated the federal Anti-Kickback Statute, according to Justice.

In addition, Justice alleged that AstraZeneca paid to use doctors’ names as authors of articles that were ghostwritten by medical-literature companies. The articles described studies that the doctors had not conducted, and they formed the basis for promotional messages about unapproved uses of Seroquel.

In a press statement, AstraZeneca denied these allegations but noted that it had entered into a five-year corporate integrity agreement with the US Department of Health and Human Services’s Office of the Inspector General.

The alleged AstraZeneca payments are quite similar to the kinds of payments that drugmakers would have to report under a transparency bill in Connecticut. As I noted last week, Pfizer (New York) is fighting the Connecticut bill, but similar provisions are already part of federal law.

The public does not appear to be on Pfizer’s side. According to an analysis of previous studies that the Journal of the American Medical Association published last week, a majority of patients and research participants believe that financial relationships between medicine and industry should be disclosed because they may influence research and clinical care. “In clinical care, patients believed financial ties decreased the quality and increased the cost of care,” according to the authors of the analysis. “In research, financial ties affected perceptions of study quality. In two studies, readers’ perceptions of journal article quality decreased after disclosure of financial ties,” said the authors.

Bills like Connecticut’s seem to enjoy broad support, and news of AstraZeneca’s settlement might strengthen it. I think that companies such as Pfizer should overcome any reservations they might have about reporting payments to physicians. They stand to gain the public’s trust, which is a valuable commodity in a competitive market.

The bill, SB-270, would require drugmakers to adopt a marketing code of compliance that, among other things, forbids them from buying meals for doctors at continuing-education events and from compensating doctors for attending such events. The bill also would require transparency in pharmaceutical companies’ interactions with healthcare providers. The General Assembly’s Public Health Committee has approved SB-270, and the bill awaits approval by the full Assembly.

In an interview with Connecticut newspaper The Day, Liz Power, a Pfizer spokeswoman, said the bill would hinder the relationship between doctors and the company’s field representatives, who provide “critical information about prescription medicines” to busy doctors. I don’t see how the bill would reduce sales representatives’ ability to convey information about their drugs. Surely they can do that without giving doctors gifts.

The employees who visited Hartford asserted that the bill would discourage drugmakers from doing business in the state. This claim might be grounded in Power’s statement to The Day that the bill would be expensive to implement. But the bill echoes the rules laid out in the Physician Payments Sunshine Act of 2009, which was signed into law in March 2010 as part of Congress’s healthcare-reform legislation. Indeed, Power told The Day that many of SB-270’s proposed regulations overlap with new federal requirements. As long as the reporting requirements and restrictions on gifts to doctors are part of federal law, it’s hard to see what Pfizer would gain by moving from Connecticut to, say, Utah.

By fighting what seems like a reasonable attempt to ensure transparency in relationships between doctors and drug companies, Pfizer ends up looking like it wants to use questionable techniques to persuade physicians to prescribe its drugs. I don’t see how the bill would cost the company a significant amount of money, especially if Pfizer will have to comply with similar federal rules anyway. For the same reason, I’m equally puzzled about how the bill could influence Pfizer to transfer jobs out of Connecticut.

So far, the company has not given clear explanations about how SB-270 would interfere unfairly with its operations or harm its bottom line. Unless the company makes a more convincing case, its resistance to the bill will seem like much ado about nothing.

According to a summary analysis of the legislation by the Kaiser Family Foundation, a nonprofit policy research firm, the new law supports CER by establishing a nonprofit Patient-Centered Outcomes Research Institute to identify research priorities and conduct research that compares the clinical effectiveness of medical treatments. The institute will be overseen by an appointed multistakeholder board of governors and will be assisted by expert advisory panels. The law specifies that findings from CER may not be construed as mandates, guidelines, or recommendations for payment, coverage, or treatment, or used to deny coverage. The funding for the institute will become available starting in fiscal year 2010 and will terminate the Federal Coordinating Council for Comparative Effectiveness Research that was founded under the stimulus bill, the American Recovery and Reinvestment Act (ARRA), which passed in February 2009, and which provided $1.1 billion in funding for CER. Following the passage of ARRA, the Institute of Medicine issued a report recommending priorities for CER.

CER seeks to evaluate and compare the implications and outcomes of healthcare strategies such as medical procedures, medicines, and other approaches to address a particular medical condition, according to a Kaiser Family Foundation analysis on CER. CER proponents say it is a valuable tool to improve the quality of healthcare and cut unnecessary costs. CER critics have raised concerns that CER could be a forebearer to healthcare rationing and would circumscribe treatments to patient-specific populations, including approaches in personalized medicine. So, for the pharmaceutical industry, is CER a good thing or a bad thing?

When CER was incorporated into the stimulus bill, the Pharmaceutical Research and Manufacturers of America (PhRMA), broadly supported the concept of CER, but noted that a long-term framework for implementing CER still had to be worked out as part of healthcare reform. “Throughout the discussion of this issue in the stimulus bill, PhRMA maintained its long-standing support for increased government funding of constructive approaches to comparative effectiveness research,” said PhRMA President and CEO Billy Tauzin in a Feb. 17, 2009 statement in commenting on the passage of the stimulus bill.

Since the healthcare legislation was passed, PhRMA has not issued a public statement on the CER provisions in the new healthcare law, but an industry group, the Partnership to Improve Patient Care (PICP), has come out in support of the CER provisions in the new law. PICP was formed in November 2008 to address CER and is comprised of healthcare, scientific, and trade associations, which includes PhRMA and the Biotechnology Industry Organization. “The Partnership to Improve Patient Care has been working for over a year in support of patient-centered CER, and we’re very happy to see it included in the final healthcare reform bill,” PIPC Chairman Tony Coelho said in a Mar. 23, 2010 statement. “Everybody is different, so it’s critical that CER reflect these differences. This legislation will help ensure that CER is used to help doctors and patients make the best treatment decisions possible and not to set coverage guidelines.” He noted that the final bill is consistent with the principles for patient-centered CER adopted and released by PIPC in 2008. PIPC said it will work with other stakeholders to advance patient-centered CER in the coming months.

It was a victory for the pharmaceutical industry that the CER provisions in the newly passed healthcare reform law do not use CER as a requirement for coverage or reimbursement, but the CER provisions, along with other measures in healthcare reform, point to a shifting focus to value-based healthcare. As outlined in the Kaiser analysis, the new law establishes a national quality-improvement strategy that includes priorities to improve the delivery of healthcare services, patient health outcomes, and the health of the population. It creates processes for the development of quality measures involving input from multiple stakeholders and for selecting quality measures to be used in reporting to and payment under federal health programs. The national strategy is due to Congress by January 1, 2011.

The shifting focus to value-based healthcare, with its emphasis on health outcomes, as a means to improve the quality of care, allocate resources more efficiently, and reduce costs, is likely to influence drug development. Clinical studies obviously will still focus on evaluating a given drug’s efficacy and safety as well as measure the effectiveness of a given drug compared with existing therapies, but the focus on value-based healthcare implies a broadening of the scope of clinical research.

For drug companies, comparative clinical research has traditionally been a tool in their own efforts to advance a particular product against competing therapies. What we see now in the movement to value-based healthcare, including CER, is a broader mindset to more critically evaluate all healthcare approaches in treating a particular condition, which includes both pharmaceuticals and non-pharmaceutical solutions. This philosophy implicitly raises the bar in clinical research and widens the competitive field to include not only drugs but also other tools such as molecular diagnostics and medical devices that can work in conjunction with or separately from drug therapies. An important issue to watch is how the underlying philosophy of value-based healthcare may alter drug-development efforts and strategies and the positioning of pharmaceutical companies in non-drug-based healthcare solutions.

As reported earlier this week in ePT, Pharmaceutical Technology’s weekly electronic newsletter, the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), and the Generic Pharmaceutical Association (GPhA), all issued press statements on the passage of healthcare reform. In general, the pharmaceutical and biotechnology industries have largely supported healthcare reform as a means to expand healthcare insurance coverage. Specific provisions, however, are receiving mixed reactions. The newly passed legislation, which sets different timelines for implementation of the multitude of measures, brings to life again the division between the innovator-drug and generic-drug industries on the regulatory requirements for biosimilars, raises concerns about the establishment of an independent review board evaluating Medicare, sets new fees on the pharmaceutical industry, but also provides measures to support drug development.

Title VII, “Biologics Price Competition and Innovation,” of HR 3590, which was signed into law earlier this week, establishes a regulatory pathway for biosimilars, which includes 12 years of data exclusivity for a biological reference product. The length of time for data exclusivity has been an area of contention between innovator-drug companies, which favored the longer period of data exclusivity, and the generic-drug industry, which advocated for a shorter time frame. With regard to the newly passed healthcare legislation, BIO supported the measures that created the regulatory pathway to biosimilars, saying “the language establishes equity with Hatch-Waxman regime,” which is the statutory framework for traditional generic drugs.

GPhA President and CEO Kathleen Jaeger, however, while acknowledging the legislation provides authority for FDA to establish a regulatory pathway for biosimilars, criticized the legislation for failing to close the so-called “evergreen loophole,” which refers to the various ways in which innovator-drug companies can extend market exclusivity for a branded drug through strategies such as authorized generics. “Until the brand evergreen loophole is closed and the indefinite brand biologic monopolies are addressed, our healthcare system will not see true savings from biogenerics for decades,” she said.

Drug pricing, always an important concern for the pharmaceutical industry, was also addressed in the newly passed healthcare reform legislation. The new law closes the so-called “doughnut hole,” or a gap in Medicare coverage for prescription drugs. During the healthcare debate, the pharmaceutical industry, through PhRMA, had made a policy commitment of $80 billion during 10 years, under which pharmaceutical companies would provide discounts for brand-name prescription drugs to close the coverage cap. According to a summary analysis by the House of Representatives, under the law, beginning in 2010, Medicare beneficiaries who go into the doughnut hole will receive a $250 rebate. After that, they will receive a pharmaceutical manufacturers’ 50% discount on brand-name drugs, increasing to 75% on brand-name and generic drugs to close the doughnut hole by 2020.

Although the closure of the doughnut hole was supported by PhMRA, the association raised concerns about a measure that would establish a 15-member Independent Payment Advisory board in charge of evaluating Medicare costs. According to a timeline analysis provided by the House of Representatives, the board would develop and submit proposals to Congress and the private sector aimed at extending the solvency of Medicare, lowering healthcare costs, improving health outcomes, and improving quality and efficiency. The recommendations and reductions would become law unless alternative recommendations are passed by Congress. In a statement, PhRMA said it had concerns with such a board that could “enact sweeping Medicare changes without action by Congress and would not be subject to judicial or administrative review,” and pledged to work with Congress to address these concerns.

The new law also imposes additional fees on the pharmaceutical industry. According to the House analysis, the new law imposes an annual, nondeductible fee on the pharmaceutical manufacturing industry allocated according to market share. The measure does not apply to companies of branded pharmaceuticals with sales of $5 million or less.

The new law also contains certain measures that would seemingly support drug development. It provides for a two-year temporary credit, subject to a $1-billion cap, to encourage investment in new therapies to prevent, diagnose, and treat acute and chronic diseases, according to the House analysis. The credit would be available for qualifying investments made in 2009 and 2010. Also, the law prohibits new health plans from dropping coverage because an individual chooses to participate in a clinical trial and from denying coverage for routine care that would otherwise be provided because an individual is enrolled in a clinical trial, according to the House analysis. The measure applies to all clinical trials that treat cancer of other life-threatening diseases.

So what is next? The overarching issue in the upcoming months will be to see whether the new healthcare package will hold and to what extent the numerous private and public interests will be able to rescind, modify, or fortify measures in the healthcare reform package. There is no easy or certain answer as to how this process will unfold, but it is clear that the debate on healthcare reform will stay in the fore of US public policy.

There is not a simple answer to that question as both the innovator-drug industry and the generic-drug industry are taking decidedly different positions. So far, the innovator-drug industry as a whole is offering a measured view of the Senate proposal. On Nov. 19, the Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice-President Ken Johnson released a statement in the wake of the Senate’s decision to proceed with debate. “While we are still reviewing the Senate bill, we remain committed to do our part to make comprehensive healthcare reform a reality this year,” he said in the statement. “We believe that all Americans should have access to high-quality, affordable healthcare coverage and services. If done in a smart way, healthcare reform will benefit patients, the economy, and the future of America. Compared to the House bill, which would have a chilling effect on medical progress in America, the Senate approach provides a much better blueprint for reform.”

PhRMA has supported healthcare reform, offering an $80-billion commitment over 10 years to close gaps in Medicare prescription drug coverage. It, however, objected to measures in the recently passed House bill, which would impose mandatory rebates in Medicare Part D coverage. “PhRMA and its member companies share the goal of closing the Medicare Part D coverage gap for affected seniors and have agreed to provide a 50% discount on brand-name medicines purchased in the so-called ‘doughnut hole,’ said PhRMA in an Oct. 29, 2009 press release. “However, the Congressional Budget Office has warned that the House bill, which imposes mandatory rebates in Part D, would ultimately lead to a 20% increase in Part D premiums paid by beneficiaries.”

In offering a more supportive position toward the Senate provision, PhRMA says that it remains committed to working with parties to get a healthcare measure passed this year. “What’s critical now is that we remain focused on the important goal of helping pass a comprehensive health care reform bill that can get to the President’s desk this year. We will continue to be a constructive partner to help meet this goal,” said Johnson in the statement.

Meanwhile, the generic-drug industry is voicing disagreement with the Senate bill. Generic Pharmaceutical Association (GPhA) President and CEO Kathleen Jaeger sharply criticized the biologics provision of the Senate healthcare reform proposal. “Just when you think the pro-BIO and PhRMA provisions in healthcare reform couldn’t get any more favorable for them, the Senate healthcare reform bill has further disappointed consumers by adding additional monopoly protection to expensive biologic medicines,” she said in a Nov. 19 statement. “Regardless of the motivation, the biologic provision in this bill takes the already egregious and unwarranted 12 years of exclusivity and extends it. The Senate leadership had the opportunity to address the deficiencies of the House HCR [healthcare reform] bill and to fulfill the Senate HELP [Health, Education, Labor and Pension] Committee’s commitment to close down a major loophole known as ‘evergreening’ and deliver a more reasonable biogenerics pathway to consumers, labor, businesses, generic manufacturers, and employers. Instead, they have provided further hurdles to access more affordable medicines.”

No doubt both the innovator-drug and generic-drug industries will be participants among the many interests in the massive upcoming discourse on healthcare reform. To put it succinctly, let the debates begin.