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NACDS reflects, looks ahead on 30th anniversary of ‘Hatch-Waxman’ Act

BY Antoinette Alexander

ARLINGTON, Va. — In celebration of the 30th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act, also known as the “Hatch-Waxman” Act, the National Association of Chain Drug Stores issued a statement to reflect on the evolution of providing patient access to generic medications and noted that it is looking forward to further progress in the years ahead.

“We laud the efforts of lawmakers such as Senator Orrin Hatch, R-Utah, and Rep. Henry Waxman, D-Calif., for their forward-thinking leadership in opening the door to make generic drugs more affordable and accessible for patients,” stated NACDS president and CEO Steve Anderson.  “As the landscape of the healthcare system has transformed in the last 30 years, generic drugs have long-surpassed the expected impact of how they would be utilized by patients.”

When enacted in 1984, it was projected that the legislation could save Americans $1 billion. Fast-forward to 2013, the Generic Drug Savings in the U.S. report, compiled by IMS Institute for Healthcare Informatics, showed that generics saved $239 billion.

“Chain pharmacy is committed to helping patients obtain cost-effective healthcare. Looking ahead to the next 30 years, we need to continue to find ways to make prescription drugs more affordable for patients,” Anderson stated.

NACDS has long-promoted policies that facilitate patient access to cost effective medications, and continues to do so in the growing area of biologic drugs: 1) patients need greater access to the generic versions of costly biologic drugs, and 2) pharmacists in all states should have the ability to substitute approved interchangeable biosimilar medications.

NACDS noted that biologic drugs, which can drastically improve patient health, are highly expensive medications. Under legislation enacted in 2010, a drug approval process was created so the Food and Drug Administration can approve generic versions of biologic drugs — known as biosimilars — with the intent of providing patients with more affordable options for these types of products. NACDS stated that it continues to work with the FDA to urge the agency to adopt policies that will facilitate greater access to biosimilar medications.

In addition, state generic substitution laws were enacted decades ago, well before the approval pathway for biosimilars was conceived. As such, the language in these state laws does not recognize or accommodate the substitution of interchangeable biosimilar drugs. According to NACDS, this must be remedied so that pharmacists can substitute interchangeable biosimilar drugs consistent with existing substitution practices for other generic drugs, and continue to help patients and payors by controlling prescription drug costs and saving overall healthcare dollars.

“We look forward to working with our industry partners like the Generic Pharmaceutical Association and others, as well as the lawmakers and policy makers to continue building on the success of the ‘Hatch-Waxman’ Act in providing affordable access to generic medications for patients,” Anderson stated.

In commenting on the anniversary of the “Hatch-Waxman” Act, GPhA president and CEO, Ralph G. Neas, stated, “Today, the generic industry’s future could not be brighter. The Hatch-Waxman law created a strong foundation for a dynamic and evolving generic drug industry, and with emerging opportunities from a global marketplace, expanded health coverage access, and the needs of an aging population, the industry has never been stronger. As we look forward to the next frontier of affordable medicines, biosimilars, a recent study by Express Scripts estimates that hundreds of billions of dollars in savings are at stake. Over 10 years, the report showed, the United States would save $250 billion if just the 11 likeliest biosimilars would enter the market.”



Neas added, “We must embrace the spirit of the Hatch-Waxman law and build on its remarkable achievements. It is essential to recognize that balancing competition with access to affordable medicines can revolutionize the market, offer consumers quality and safe choices, and inspire innovation. ”
 

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Revlon CFO Lawrence Alletto steps down

BY Antoinette Alexander

NEW YORK — Revlon revealed in a filing with the Securities and Exchange Commission that, effective Sept. 30, Lawrence Alletto, its EVP, CFO and chief administrative officer, is leaving the company after about a year on the job to pursue other opportunities.

In the SEC filing, Revlon stated that, “Alletto’s departure from the company is not the result of any issue or concern with the company’s accounting, financial reporting or internal control over financial reporting.” 

Succeeding Alletto is Roberto Simon, who will assume the role of EVP and CFO, effective Sept. 30.

Previously, Simon served as the company’s SVP, global finance since joining the company in October 2013 as part of its acquisition of The Colomer Group.  Prior to joining the company and since 2002, Simon served in various senior finance positions of increasing responsibility at The Colomer Group, including most recently serving as The Colomer Group’s CFO since October 2011.

Alletto has worked together with Simon to ensure a smooth transition of the company's financial functions.

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Study: Data breaches becoming ‘ubiquitous’ as 43% of companies report incidents

BY Antoinette Alexander

COSTA MESA, Calif. — Nearly half of companies have suffered from at least one security incident, according to a new study, prompting many to implement data breach response plans and ramp up investments in security technologies. Is it enough?

As data breaches make headlines worldwide, Experian Data Breach Resolution released on Wednesday a new study with the Ponemon Institute on data breach preparedness. The second annual study — “Is Your Company Ready for a Big Data Breach?” — found that executives are concerned about the effectiveness of their data breach response, despite taking the basic steps to be prepared.

"While more organizations have data breach preparedness on their radar and have developed a response plan, a majority of companies are not putting the support and resources behind having it truly be effective," said Michael Bruemmer, VP, Experian Data Breach Resolution. "A checklist response plan alone doesn't mean you're prepared. There should be an incident response team in place that practices the plan and ongoing investment from the C-suite to ensure technologies are up-to-date, external breach experts are secured and selection of an identity protection product for affected customers is determined prior to an incident to ensure a quick and smooth response."

Key findings from the study include:

Companies understand the importance of data breach preparedness

  • Data breaches are becoming ubiquitous with almost half (43%) of organizations surveyed having suffered at least one security incident, up 10% from 2013;
  • As a result, more companies have a data breach response plan in place (73%), up 12% from 2013; and
  • Forty-eight percent of organizations increased investments in security technologies in the past 12 months.

Confidence amongst senior executives to manage a data breach remains low

Despite increased security investment and having incident response plans in place, when asked in detail about the preparedness of their organization, survey respondents were not confident in how they would handle a major issue.

  • Sixty-eight percent of respondents felt unprepared to respond to a data breach;
  • Most haven't or don't regularly update their plan (78%) to account for changes in threats or as processes at a company change;
  • Thirty percent of respondents felt their data breach response plan was ineffective; and
  • Concerns are not just operational. Many companies were more concerned about threats being harder to manage for IT security teams.

Executives recognize what needs to happen to improve their incident response

  • The vast majority of executives (70%) surveyed want more oversight and participation from board members, chairman and CEO for data breach preparedness;
  • Seventy-seven percent suggested more fire drills to practice data breach response would help them be more prepared;
  • Respondents ranked identity theft protection products and access to a call center as the two most important services a company should provide customers following a breach; and
  • Sixty-nine percent indicated additional funding as a major need to improve response activity.

"Compared to last year's study results, survey findings show encouraging signs that organizations are beginning to better prioritize data breach prevention, but more needs to be done," said Larry Ponemon, chairman and founder of the Ponemon Institute. "Companies should be careful of not becoming complacent because they have a response plan in place or just completed a security audit. Preparedness requires ongoing maintenance and diligence."

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