Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Pharma Sis, Mylan CEO, Hits Her EpiPen Marketing Target: Moms! Price Gouging Followed

Pharma Sis, Mylan CEO, Hits Her EpiPen Marketing Target: Moms! Price Gouging Followed | Pharmaguy's Insights Into Drug Industry News |

Mylan pharmaceutical company has a virtual monopoly on EpiPens after a voluntary recall felled their only competitor*, Sanofi’s Auvi-Q, over possible dosage miscalibrations. It’s not the drug being delivered that brings the bucks, though—epinephrine’s a cheap generic. The cost trickery is in the delivery system, the Mylan EpiPen.


The EpiPen’s been around since 1977, but Mylan acquired the autoinjector—which precisely calibrates the epinephrine dosage—in 2007. The patient now pays about 400% more for this advantage to receive a dollar’s worth of the lifesaving drug: EpiPens were about $57 when Mylan acquired it. Today, it can empty pockets of $500 or more in the US (European nations take a different approach to these things).


According to NBC, Mylan’s profits from selling EpiPens, which they have aggressively, famously marketed with brilliant success, hit $1.2 billion in 2015. That year, Bloomberg reported that the epinephrine-delivery system represented 40% of Mylan’s operating profits. Bloomberg calls Mylan’s marketing of the EpiPen “a textbook case in savvy branding.”


It’s what the market will bear, so what’s the problem, right?


Only this: Somewhere, right now, a cash-strapped parent or budget-limited patient with a severe allergy will skip acquiring an EpiPen. And someday, they will need it in a life-threatening situation involving exposure to a trigger … and they won’t have it. And they will die. Because they couldn’t afford the delivery mechanism for $1 worth of a drug to keep them alive. Two turning points, a death, and one company at the crossroads.



Shkreli’s shenanigans earned him the moniker “pharma bro,” but the “bro” in the Mylan case is no bro: She’s ‘pharma sis’ Heather Bresch, now the company’s CEO. The “textbook” marketing plan she hit on expanded the “find” target—one of the three goals of any pharmaceutical company—reaching for parents of children with allergies. The “what-if” fears of parents are a rich vein to tap, one that clearly has proved immensely valuable to Mylan.


The “find” was a huge success. And once those parents were found, hitting the second goal of a pharmaceutical company—“start,” as in “start them on your product”—was almost inevitable. The question now is, in the face of prohibitive pricing, syringe-hacking, and all of this negative publicity—in which even Martin “Pharma Bro” Shkreli sees a spot of moral high ground where he can stand—Can Mylan continue to hit that third aim: Keep?

Pharma Guy's insight:

Read “Mylan CEO Heather Bresch: We needed tax inversion in order to grow”;

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New Study Finds Programs Designed to Protect Safety Being Widely Abused, Delaying Generic Choices for Consumers

New Study Finds Programs Designed to Protect Safety Being Widely Abused, Delaying Generic Choices for Consumers | Pharmaguy's Insights Into Drug Industry News |

The ongoing abuse of FDA drug safety programs to prevent generic competition is costing the American health care system and patients $5.4 billion in annual pharmaceutical spending that could be saved if 40 drugs examined in a Matrix Global Advisors report released today were allowed to come to market. The study, commissioned by the Generic Pharmaceutical Association, also found that after biosimilars enter the market, misuse of Risk Evaluation and Mitigation Strategies (REMS) and other restricted access programs would result in approximately $140 million in lost savings for every $1 billion in biologics sales.

“For patients waiting for generic alternatives to expensive brand medicines, every day counts. For lawmakers struggling to balance the budget, every dollar matters,” said Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association (GPhA). “This study shows that by using safety programs as a smokescreen for anti-competitive practices, some brand companies are delaying generic choices for patients and driving up drug costs.

Further, allowing these kinds of abuses to continue unabated threatens the cost savings potential around the next frontier of innovation: biosimilars. The data reveals that allowing these practices to go unchecked will have exorbitant and spiraling costs. These critical medicines have increasingly become the standard of care for many serious conditions, accounting for $92 billion of U.S. drug spending in 2013. This could mean tens of billions more in lost savings in the future.”

The study, titled Lost Prescription Drug Savings from Use of REMS Programs to Delay Generic Market Entry, examines the practice of abusing REMS and “Restricted Access Drug” programs to deny generic drug firms access to samples of brand drug products. Without access to these samples, which traditionally have been purchased by generic drug applicants through wholesalers, manufacturers cannot conduct appropriate testing and secure subsequent approval of generic medicines. Refusing access to samples effectively delays generic alternatives for patients, and extends brand product monopolies. The study was based on 40 products identified in a confidential survey of eight generic manufacturers and conducted from December 2013 to March 2014.

“This report is the first clear picture of the costs imposed by misuse of REMS and other restricted access programs,” said Alex Brill, CEO of Matrix Global Advisors. “By finding ways to obstruct the generic approval process, brand companies protect their market share and keep generics off the market. Our research also reveals that the practice clearly extends beyond traditional REMS programs. In more than 20 cases, manufacturers reported brand companies using non-REMS restrictions to block access.”

The key findings of the study include:

• REMS programs are widespread.
o FDA requires REMS programs for almost 40 percent of new drug approvals, according to briefs presented in litigation on this issue.
• Brand manufacturers have also begun imposing distribution restrictions on non-REMS products.
o Manufacturers report that brand drug companies have used non-REMS restrictions to block access to more than 20 products.
• These abuses cost the government, patients, and the health system billions of dollars.
o Annually, $5.4 billion in savings is lost from 40 generic small-molecule products whose market entry is currently delayed as a result of misuse of REMS and other restricted access programs.
o The federal government bears a third of this burden, or $1.8 billion.
o Private insurance companies lose $2.4 billion.
o Consumers pay $960 million in extra out-of-pocket costs.
o State and local governments, and other small payors, lose savings of $240 million.
• If it continues, this issue also can be expected to have a major negative impact on savings from biosimilars once the FDA provides final guidance for biosimilars.
o Delaying biosimilar entry by restricting access to samples would result in approximately $140 million in lost savings for every $1 billion in biologics sales.

Pharma Guy's insight:

Read the full report:
Lost Prescription Drug Savings from Use of REMS Programs to Delay Generic Market Entry , Matrix Global Advisors, July 2014.

Key findings and issue overview

H. Fai Poon's curator insight, July 24, 2014 7:55 PM

This is just wroung