Q&A: Prez perspective

BY Alaric DeArment

In September, the Generic Pharmaceutical Association announced the appointment of Ralph Neas — former president and CEO of the National Coalition on Health Care — as its new president and CEO, replacing Kathleen Jaeger, who stepped down as president and CEO of the organization in May 2010. Drug Store News recently spoke with Neas about his plans and vision for the organization and the industry as a whole.

DSN: Your predecessor, Kathleen Jaeger, was from the industry, as a former pharmacist. How do you plan to draw from your background in civil rights during your tenure at the GPhA?

Ralph Neas: Prior to joining GPhA, I had the opportunity to work on healthcare issues going back to my days with Republican Sens. Edward Brooke and David Durenberger. In addition, I have had the privilege of serving as the CEO of two of the largest and most diverse coalitions in the nation, the Leadership Conference on Civil Rights and the National Coalition on Health Care. Those experiences taught me about coalition building and how to work collaboratively to achieve a bipartisan consensus on important national issues. Additionally, they provided extensive opportunities to be an advocate before the legislative branch, the executive branch and the media. Hopefully, my training in how to frame a debate and define an issue will be an asset in my new job and help make GPhA a more proactive, aggressive and effective association.

DSN: With the departure of Teva Pharmaceutical Industries and the longer exclusivity period for biotech drugs before they face competition from follow-on biologics than your group had hoped for in the Affordable Care Act, how do you plan to guide the GPhA going forward?

Neas: Teva has rejoined GPhA and is playing a leading role as a member of both our board of directors and executive committee. After the Federal Trade Commission recommended zero years — and the administration had recommended seven — for the exclusivity period for biotech drugs, it was a major and inexplicable disappointment for Congress to pass a 12-year period of exclusivity. I believe that a massive and effective public education campaign can change the current situation and also help create a workable pathway to biogenerics. If something is not done, I fear that exponential growth of biologics over the next 10 to 20 years, without adequate generic alternatives, could bankrupt the healthcare system and the national economy.

DSN: What do you see as the greatest challenges facing the generic drug industry right now? 

Neas: As I mentioned, one of the biggest challenges we face right now is ensuring that a workable approval pathway for biogenerics is implemented by the [Food and Drug Administration]. It is critical that the approval process is not fraught with unnecessary and unwarranted roadblocks, such as mandatory clinical trials or repetitive exclusivity periods. …

It is also vital that the FDA and the Office of Generic Drugs receive adequate funding so that consumers continue to have access to safe and affordable generic medicines in a timely manner. Along those lines, we have just completed a historic generic user fee agreement that will provide the agency with nearly $300 million in additional funding each year. We must make sure that this added funding is used to alleviate the current backlog of pending generic applications and conduct additional foreign inspections.

In addition, we must continue to work to stop any kind of restriction on patent litigation settlements. The fact is that these settlements do result in earlier access to generic medicines and allow generic manufacturers to have date-certain launches of their products.

DSN: What do you see happening in the industry over the next several years? 

Neas: No one knows for sure, of course. But it is likely we will see continued consolidation through mergers and acquisitions in both the brand and the generics sectors — and not just generics manufacturers buying other generics companies or brand companies merging with each other. Rather, we could see more companies emerging in the Novartis model, where brand and generics businesses exist within the same company.

As I mentioned before, we will certainly also begin to see an increase in the presence of biogenerics. And after emerging from the forthcoming patent cliff, generic utilization likely could top 80%. …

DSN: How do you plan to deal with various attempts to ban patent settlements?

Neas: We believe we can defeat attempts to ban patent settlements by sharing the facts with legislators and the public about how these agreements are, in reality, pro-consumer and pro-competitive. Patent settlements have provided millions of consumers with access to affordable medicines far earlier than if they were forced to wait for a branded product’s patents to expire, and in the process have saved consumers hundreds of billions of dollars.

If there are any patent settlements that are not pro-consumer, the Federal Trade Commission and the Department of Justice currently have the authority to challenge such settlements in court. What the FTC is attempting now would overturn nearly a century of intellectual property law and undermine an effective legal remedy that has benefitted millions of consumers.


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With 2012 near, generics still face challenges

BY Alaric DeArment

In February, Drug Store News discussed three issues concerning generic drugs that would figure prominently throughout the year: drug safety, user fees and patent settlements.

None of those issues have gone away. Fears recently surfaced that Ranbaxy might not get to launch its generic version of Pfizer’s cholesterol medication Lipitor (atorvastatin) this month due to concerns about safety at two of its plants in India, but it appears the scheduled launch is back on track. The Food and Drug Administration’s Office of Generic Drugs needs increased funding to address its massive backlog of generic drug approval applications, something that user fees would address, but the Generic Pharmaceutical Association has been pushing Congress to maintain funding for the OGD. Meanwhile, the Federal Trade Commission and such members of Congress as Sens. Herb Kohl, D-Wis., and Chuck Grassley, R-Iowa, continue their push to ban patent litigation settlements that involve any type of payment from branded drug companies in exchange for generics companies holding off product launches, even when those product launches happen months or years before the branded drug’s patents expire.

But IMS Health VP industry relations Doug Long recently told Drug Store News of another major issue emerging. “What’s really come to the forefront is this drug-shortage stuff,” Long said. According to the GPhA, the reasons for drug shortages are numerous and complex: insufficient supplies of raw materials; inadequate and delayed communications about shortages; changes in clinical practices that have altered volume production; and stockpiling of drugs within the gray market.

In September, the GPhA called for a broad effort by various stakeholders — ranging from branded and generics drug makers to component suppliers, from healthcare providers to regulators — to combat the problem.

Whatever the issues for 2012 turn out to be, it’s the trends in various disease-state markets that will continue to drive prescribing, dispensing and marketing of generic and branded drugs alike. Click here to see the highlights.


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Seniors tend to ‘get the point’

BY Rob Eder

I know this older guy at my gym — I call him “The Professor,” mostly because he used to teach journalism, but also because it’s more fun to say and easier to remember than his actual name. He’s 85 now, and he says if he doesn’t get to the club to swim laps and sit in the steam room at least three times a week, he feels like he’s doing something wrong. He says he feels the same way about flu shots and all vaccinations for that matter.

I like The Professor a lot. We’re both journalists, both gym rats. We also both grew up in the city, and our mothers — despite the 43-year gap in our ages — both saved their money to send us away to summer camp to keep off us out of trouble.

But that’s where our experiences begin to differ. I remember the summer we had the big lice outbreak, and we had to shave a bunch of kids’ heads and shampoo the others with Quell. He remembers the year a polio outbreak shut down his camp and sent all of the kids home early.

The Professor is a living, breathing example of something Raymond Fabius, chief medical officer at Thomson Reuters healthcare business unit, commented upon in the context of his company’s recent survey regarding consumers’ opinions about vaccines. “Ironically, these surveys are a testament to the effectiveness of vaccines — older people remember what illnesses like polio did to cripple and kill patients, but the younger generation has never seen someone with polio.” 

It’s frightening what people actually think vaccines will do to them. According to the Thomson Reuters survey, 24% of people say their opinions of vaccines have changed in the past five years, and among them, 59% said their views on vaccines have become less favorable. More than 26% expressed apprehensiveness over vaccine safety, with the highest level of worry among parents with children under 18 years old (30.8%), and those ages 65 years and older with the least concern (18.5%).

According to the research in which more than 100,000 households were polled between Aug. 1 and 16:

  • 47% worry that vaccines could impact long-term health; 

  • 46% worry about side effects;

  • 21% believe vaccines can cause autism;

  • 9% believe vaccines can be linked to cancer; 

  • 7% believe vaccines can be linked to diabetes, and;

  • 6% believe vaccines can be linked to heart disease.

Another survey, conducted by the University of Michigan, found that 1-in-10 parents use a different vaccination schedule for their children from the one recommended by the Centers for Disease Control and Prevention. The most commonly delayed vaccine among this group: meales-mumps-rubella (45%).

So it can’t be too hard to imagine that cases of the measles in the United States are at their highest levels in 15 years, with some 212 cases in 2011, according to research presented in late October at the Annual Meeting of the Infectious Diseases Society of America. In 13% of these cases, the infected was younger than 1 year old. Since that’s too young for a baby to get their first MMR — recommended between 12 months and 18 months, according to the CDC — it means those infants were exposed to someone else that wasn’t up to date on their vaccinations.

Retail pharmacy has done a strong job of improving immunization rates in this country; so have retail clinics. Last year, more than 18% of adults got their flu shot in a retail setting, according to the CDC. That’s up from about 7% five years ago. That’s an important contribution to our nation’s public health. Clearly, you’re making a dent here.

Studies like this give you an idea where to focus your messaging efforts — and to which segments of your customers. People like The Professor tend to get it.

Rob Eder is the editor in chief of The Drug Store News Group, publishers of Drug Store News, DSN Pharmacy Practice, PharmacyTech News, Specialty Pharmacy and Retail Clinician magazines. You can contact him at [email protected].



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N.SMITH says:
Nov-22-2011 10:31 am

Just a comment...this is a pharmacy magazine and yet, the trade name for lindane shampoo was spelled incorrectly. The trade name was spelled Kwell, not Quell. But then, like The Professor I am an old-timer and remember how it was.