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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Hillary Clinton to Unveil Plan to Address ‘Excessive’ Increases in Drug Prices

Hillary Clinton to Unveil Plan to Address ‘Excessive’ Increases in Drug Prices | Pharmaguy's Insights Into Drug Industry News |

Amid an uproar over the steep increase in the cost of the EpiPen, a lifesaving injection device for people with severe allergies, Hillary Clinton will announce a plan on Friday to crack down on unwarranted rises in price for prescription drugs that have long been available.

As part of the plan, Mrs. Clinton would create a team of federal officials that would seek to protect consumers by monitoring price increases. The plan also lays out several actions that the government would be able to make in response to “excessive” rises in price, including taking steps to expand access to treatments and imposing penalties on drug companies, such as fines.

“Over the past year, we’ve seen far too many examples of drug companies raising prices excessively for longstanding, lifesaving treatments with little or no new innovation or R. & D.,” Mrs. Clinton said in a statement. “It’s time to move beyond talking about these price hikes and start acting to address them.”

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On TV DNC May Go Easy on Pharma, But on Paper It Swings Away!

On TV DNC May Go Easy on Pharma, But on Paper It Swings Away! | Pharmaguy's Insights Into Drug Industry News |

Democrats aren’t planning any major health policy discussions or new proposals at the convention, a senior Democrat close to the Hillary Clinton campaign said.


It could be good news for the drug industry, if it means avoiding a prime-time bashing on drug prices, an issue Clinton has spoken about on the campaign trail. The final Democratic Party Platform, on the other hand, doesn’t let pharma off easy.


The platform, released Friday, takes a number of swings at the industry. It pledges to “crack down on price gouging” and cap consumers’ out-of-pocket monthly costs. Those caps are usually okay with the drug industry, but disliked by insurers. The platform also calls for allowing the importation of prescription drugs, letting Medicare negotiate drug prices, and an end to “pay-for-delay” deals--where a brand drug company pays a generic maker to keep a product off the market.


Democrats also urge the federal government to change the DEA’s scheduling of marijuana and provide “a reasonable pathway” for legalization. States should be able to decriminalize or provide medical access if they choose to do so, the platform adds.

Pharma Guy's insight:

Read “Big #Pharma Likes Hillary”; 

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Big #Pharma Likes Hillary. Sanders & Trump? Not So Much!

Big #Pharma Likes Hillary. Sanders & Trump? Not So Much! | Pharmaguy's Insights Into Drug Industry News |

The pharmaceutical industry has donated $589,344 to Hillary Clinton's campaign, according to the nonprofit research group Center for Responsive Politics. That's more than any other candidate — despite Clinton's proclamation that she's proud to call the pharmaceutical industry her enemy.

"Price gouging like this in the specialty market is outrageous," Clinton tweeted in September, referring to the now-infamous decision by Turing Pharmaceuticals to raise the price of a decades-old medicine by 5,000 percent overnight. "Tomorrow I'll lay out a plan to take it on."

That was Sept. 21. 

Clinton hasn't let up on drugmakers. Last week, she released a campaign ad directly targeting Valeant Pharmaceuticals, another pharmaceutical company in the crosshairs for hiking prices of old medicines (though Valeant has since run into other troubles).

The contributions in support of Clinton come mainly from individual donors who work for pharmaceutical companies, according to the Center for Responsive Politics. They may also include contributions from political action committees associated with drug companies.

And despite Clinton's antipharma rhetoric, some say she may actually be the industry's safest choice.

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Hillary Clinton Vs. Pharmaceutical DTC Ads: Deja Vu All Over Again!

Hillary Clinton Vs. Pharmaceutical DTC Ads: Deja Vu All Over Again! | Pharmaguy's Insights Into Drug Industry News |
If Hillary Clinton has her way, your TV watching may be less crowded with ads for "low T" and restless leg syndrome.

Clinton will call for cracking down onpharmaceutical drug ads by denying tax breaks for direct-to-consumer marketing and requiring the Food and Drug Administration to pre-clear the ads for accuracy and clarity.

The aim would be to push companies to invest more in research and development than marketing, especially taxpayer subsidies.

Clinton would also expand the availability of generics by boosting the FDA’s capacity to approve the drugs, and she’d decrease the intellectual property protections for expensive “biologic” drugs so generics could be produced faster. 

And she’d allow Americans to import cheaper drugs from Canada and other foreign country where the drugs are cheaper.

Pharma Guy's insight:

Poll results: Should the Tax Deduction for DTC Advertising Expenses be Eliminated? 

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FDA is Cause of Mylan's Monopolistic Pricing of EpiPen, Says WSJ. Allergist Has Cure.

FDA is Cause of Mylan's Monopolistic Pricing of EpiPen, Says WSJ. Allergist Has Cure. | Pharmaguy's Insights Into Drug Industry News |

Mylan has raised the price of EpiPen in semiannual 10% to 15% tranches so that a two-pack that cost about $100 in 2008 now runs $500 or more after insurance discounts and coupons. Outrage seems to be peaking now because more families are exposed to drug prices directly though insurance deductibles and co-pays, plus the political class has discovered another easy corporate villain.


Still, the steady Mylan rise is hard to read as anything other than inevitable when a billion-dollar market is cornered by one supplier. Epinephrine is a basic and super-cheap medicine, and the EpiPen auto-injector device has been around since the 1970s.


Thus EpiPen should be open to generic competition, which cuts prices dramatically for most other old medicines. Competitors have been trying for years to challenge Mylan’s EpiPen franchise with low-cost alternatives—only to become entangled in the Food and Drug Administration’s regulatory afflatus.


Approving a generic copy that is biologically equivalent to a branded drug is simple, but the FDA maintains no clear and consistent principles for generic drug-delivery devices like auto injectors or asthma inhalers. How does a company prove that a generic device is the same as the original product if there are notional differences, even if the differences don’t matter to the end result? In this case, that means immediately injecting a kid in anaphylactic shock with epinephrine—which is not complex medical engineering.


But no company has been able to do so to the FDA’s satisfaction. Last year Sanofi withdrew an EpiPen rival called Auvi-Q that was introduced in 2013, after merely 26 cases in which the device malfunctioned and delivered an inaccurate dose. Though the recall was voluntary and the FDA process is not transparent, such extraordinary actions are never done without agency involvement. This suggests a regulatory motive other than patient safety.


Mrs. Clinton claims the EpiPen price hikes show the need for price controls, and she says she’ll require drug makers to “prove that any additional costs are linked to additional patient benefits and better value.” Somebody in Congress should require the FDA to justify how its delays are advancing the same goals.

Pharma Guy's insight:

Comment from an allergist: What to do?


Well, there is a simple fix. Physicians such as I, an allergist, should simply draw up an appropriate dose of generic epinephrine from a vial into a sterile 1 ml syringe, cap the syringe, and give the patient and/or family a quick demo of how to use this in case of a reaction. Send them off with a handout showing the process, for their review.


The cost of the syringe and ingredients? About $3. Speaking for myself, I would probably just give it away, and subsume the expense in the consultation charge. Epi is somewhat unstable, so the product would need to be renewed in a few months. No big deal.


Now I will hear from lawyers and bureaucrats telling me what an awful idea this is . Go at it, boys and girls (and jerks).

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Ian Read, Pfizer's CEO, Not Worried About Clinton or Trump Lowering Drug Prices

Ian Read, Pfizer's CEO, Not Worried About Clinton or Trump Lowering Drug Prices | Pharmaguy's Insights Into Drug Industry News |

Just this month… Pfizer's CEO, Ian Read, told attendees at a Sanford Bernstein investors conference that he doesn't see much difference between the policies of Hillary Clinton and Donald Trump as far as helping or harming pharma.


Although Hillary voiced support for giving Medicare the authority to negotiate drug prices, Trump has also supported the idea. On the other hand, both candidates have taken positions to support pharma's profiteering at the expense of U.S. consumers and taxpayers. As noted by journalist Lee Fang, when Hillary was a Senator she supported legislation that extended exclusivity for biological drugs to twelve years, "making it harder to bring cheaper generic drugs to market." Then last fall, as a candidate, she favored a contrary position that would end exclusivity after seven years.


"Trump’s health care policy plan," according to Fang, "includes an idea to turn Medicaid into a block grant, meaning states may shift money allocated for health care to other priorities."


Contrary to Hillary's shrug about donations not influencing policies, it matters who gives money to presidential candidates and it's also important to uncover the kinds of deals the candidates make with those donors in return for the contributions.


Is there much room to choose between Hillary and Trump when it comes to taking up the interests of the American public on drug prices? Pfizer's CEO Read has carefully examined their policies with an investor's eye and his subordinates have spoken with representatives of both campaigns at length. As noted above, he doesn't see much difference and, frankly, he doesn't really think either one offers much reason for him to worry.


Odd as it may appear, we agree with Mr. Read on this one.

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Pharma to Sanders: "No Money for you, but Clinton? Yes!"

Pharma to Sanders: "No Money for you, but Clinton? Yes!" | Pharmaguy's Insights Into Drug Industry News |

Sen. Bernie Sanders (I-Vt.) has criticized Democratic presidential rival Hillary Clinton for taking millions from pharmaceutical companies in a new fundraising email that frames her as beholden to the industry.  

"I don't go around asking millionaires and billionaires for money. You know that. I don't think I'm going to get a whole lot of contributions from the health care and pharmaceutical industries," he wrote in the note from Wednesday.
Sanders went on to remind supporters that he turned down a donation from Martin Shkreli, the CEO who raised prices on AIDS medications and is now charged with financial crimes. Both Sanders and Clinton repudiated Shkreli when that decision went public. 
Then Sanders shifted toward a critique on Clinton.
"Secretary Clinton, on the other hand, has received millions of dollars from the health care and pharmaceutical industries, a number that is sure to rise as time goes on," he wrote, arguing that Clinton has raised more money from the healthcare industry than the top three Republican candidates combined. 
"Now, and let's not be naive about this, maybe they are dumb and don't know what they are going to get? But I don't think that's the case, and I don't believe you do either."
Clinton has raised about $1.1 million from the pharmaceuticals or health products industries this cycle, according to data from Open Secrets. That's the 14th highest total from any industry or group that has given to Clinton, according to Open Secrets. The group giving the most money to Clinton — $7.66 million — is retirees.

In an email, he criticized Clinton for those donations.

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