Is Pharma Part of Problem or Solution to Current State of US Economy?

Is Pharma Part of Problem or Solution to Current State of US Economy?

When Americans were asked "Thinking about the role each of the following sectors played in the current state of the American economy, do you think each of the following sectors is a part of the problem, a part of the solution, or are you unsure?," only 15% said the pharmaceutical industry was part of the solution, according to the 2012 Harris Poll Annual RQ survey. 50% said the industry was part of the problem (see chart below):

According to Harris, that puts the drug industry on the cusp of being a "malefactor" - an industry that Americans blames for economic woes. You can find the complete Harris report here.

Meanwhile, PhRMA, the industry's trade association in the U.S., continues to churn out press releases that warns Americans that if the government passes such-and-such law or over-regulates such-and-such activity of the pharmaceutical industry, it will result in the loss of thousands, nay millions!, of American jobs.

For example, in a response to the President's Fiscal Year 2013 Budget, PhRMA stated "America's biopharmaceutical industry is a key driver of economic growth; the President's proposed budget would weaken our ability to innovate and create jobs. This is not an investment in America's future and these proposals should not be considered" (see "PhRMA Statement on the President's Fiscal Year 2013 Budget").

Of course, the drug industry can be both part of the solution and part of the problem. It depends on whose problem/solution you are talking about.

It's part of the solution for white collar workers who work in the U.S. pharma industry, have Rx medical coverage, and can afford prescription drug co-pays. Blue-collar workers and retired folk who depend more on government "safety nets," however, may see  high drug prices and the drug industry's antipathy toward Medicare rebates as part of the problem. The latter are not among the typical U.S. pharma work force since the drug industry is shipping more and more blue-collar manufacturing jobs overseas to countries like China.

Not only does this NOT support jobs in the U.S., it also endangers our drug supply.

In a story about counterfeit Avastin in the U.S., the link between overseas drug manufacturing and counterfeit or tainted drugs in the U.S. was suggested: "Most Americans don't question the integrity of the drugs they rely on. They view drug counterfeiting, if they are aware of it at all, as a problem for developing countries. But the latest incident, which follows the appearance of other fake drugs in the U.S.—including counterfeits of the weight-loss treatment Alli and the influenza treatment Tamiflu—suggests it is a growing risk, especially as more medicines and drug ingredients sold in the U.S. are made overseas [my emphasis; see "Roche warns of fake cancer drug in US"). For more on this, see "Unsafe Drugs: Is It Counterfeiters or the Supply Chain That's the Problem?"

Is Pharma Part of the Problem or Solution to America's Economic Woes?
	Solution
	Problem
	Both, as you say
	Unsure

Should the US Government Step in to Ease the Current Drug Shortage Crisis?

Should the US Government Step in to Ease the Current Drug Shortage Crisis?

"The drug industry is floundering in its ability to provide the public with many of the basic medicines that are absolutely required for the treatment of a host of diseases," said Paul Torrence, former Section Chief, MIH, in a recent OpEd piece (see here).

Torrence called for a National Institute of People's Medicine that "would ensure that drug inventories are always well stocked. It would additionally be the driver and funder of cutting-edge drug discovery and development for antibiotics. Working through out-sourcing and contract mechanisms, the NIPM could rejuvenate research funds-deprived academics and mobilize small pharma to manufacture requisite medicines.

According to the FDA, "In 2010, there were 178 drug shortages reported to the U.S. Food and Drug Administration, 132 of which involved sterile injectable drugs. In 2011, FDA has continued to see an increasing number of shortages, especially those involving older sterile injectable drugs. These shortages have involved cancer drugs, anesthetics used for patients undergoing surgery, as well as drugs needed for emergency medicine, and electrolytes needed for patients on IV feeding" (see Drug Shortage FAQs).

Various causes of the current crisis have been suggested: (1) manufacturing quality issues, (2) market manipulation (eg, price gouging), (3) mergers of pharma companies who cut out low profit margin drug lines, and (4) lack of profits to be made from certain generic drugs.

Whatever the cause, the American Society of Health-System Pharmacists (ASHP) calls the current drug shortage in the US a "crisis" (view this video -- interview at 36 mins, 30 seconds).

The last time we heard of a crisis affecting the entire nation was the 2008 "financial" crisis. That was met with swift action by the US government, which intervened in the market to help ward off the crisis in lending (ie, shortage of money).

If the government can address a national money shortage crisis, why can't it also address a national drug shortage crisis?

Can the United States Ensure an Adequate Supply of Critical Medications?

That's the question ASHP asked in an FDLI Food & Drug Policy Forum article (attached to above cited post), the introduction to which states:

"This dramatic rise in the extent, duration and severity of shortages is occurring in an environment that is characterized by a near absence of communication between drug manufacturers and the Food and Drug Administration (FDA). This lack of transparency is a significant barrier to efforts to address drug shortages, and it represents a real and growing danger to patient safety. FDA has worked diligently to address this issue, but this work is hampered by the agency’s inability to require reporting of information that could be instrumental in minimizing the impact of a shortage or averting it all together."

More resources:

• Cancer drug shortages getting worse, FDA says (USA Today)


• Cancer Drug Shortage: Why Is This Not Front-Page News? (Health Beat Blog)

[This post originally appeared in Pharma Marketing Blog. 

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Pharma's 2010 Christmas Wish List for Santa

Pharma's 2010 Christmas Wish List for Santa

A few people helped me put together a short wish list for the US pharmaceutical industry to send to Santa this year (you can still vote or write-in your item to include on the list; see survey here).

There are only 3 items on the list so far that merit Santa's urgent attention:

(1) Left over from last year's list: Guidance from the FDA on how it will regulate drug promotion on the Internet and social networks. This, of course, is the most important item on the list. In last year's letter to Santa (find it here) pharma said: "Do I need to mention how much we would like guidance from the FDA on how it will regulate drug promotion on the Internet and social networks? Right now, we are really hurting because we cannot advertise on Google."

Recently, a Time Magazine journalist interviewed me for an article he's writing on pharma's use of social media. He was shocked to learn that the lack of guidance from the FDA is holding pharma back from doing more on social networks. Of course, I've always maintained that this is a red herring used as an excuse for the unwillingness of most product managers to do something different and essentially unproven.

According to a new Deloitte report titled, “To Friend or Not? New Insights About Social Networks in the Life Sciences Industry," undefined Food and Drug Administration (FDA) guidelines, consumer privacy concerns and a lack of a clearly demonstrated return on investment are the top three hurdles to widespread adoption of social media by the pharmaceutical industry (see more survey results here). Nevertheless, 65% of survey respondents say their company uses or plans to use social networks at a company level in some capacity in the next year.

(2) Everybody seems to have an itch to modify the healthcare reform law. So it's no surprise that 22% of respondents to my survey chose Amend the healthcare reform law so that drug industry won't have to help finance the Medicare "donut hole" through discounts for prescription drugs as an item to include on Santa's list.

As reported by FiercePharma, "starting next year, drugmakers have to give a 50 percent discount on branded drugs for people who fall into the gap, which is between $2,830 and $6,440. Over 10 years, the cost of closing the hole could cost pharma $32 billion, the [Wall Street] Journal reports."

Two pharma companies have responded very differently to this "deal" with democrats to help cover the gap in Medicare drug coverage. Whereas Lilly hemmed and hawed and skirted the issue and mainly defended high drug prices (see "Why Price Controls Are Not The Right Answer" and my comments here: "LillyPad Launches Specious Rocket Attack Against Drug Price Control Straw Man"), AstaZeneca seized the moment to support the coverage and explain how else it is helping senior citizens pay for their prescription drugs (see "Our Fair Share: Closing the Coverage Gap").

Although filling the "Medicare "Doughnut Hole" will cost pharma less than 1% of US sales (see here), it can't hurt to ask Santa for a reprieve.

(3) Of equal importance to the doughnut hole wish is pharma's wish that the FDA adopt A regulatory pathway for the approval of biosimilars that the drug industry can live with. 22% of my survey respondents voted for this item. Biosimilars are generic versions of large-molecule patent drugs (biologics).

At one point in the negotiations with FDA, the drug industry argued that biosimilars need to be tested in humans before being approved as generic substitutions for patented, FDA-approved biologics. Marc Monseau, Director of Corporate Communications at Johnson and Johnson, once wrote: "These products [biosimilars] would be 'similar' to a branded product, but they would not be the 'same' and therefore, scientists do not consider them to be generics. Since laboratory testing isn't enough to detect many of the clinically important differences in biologics, testing in humans will be necessary to ensure their safety and efficacy."

Nowadays, however, the industry is focused on making sure new regulations "should include a data exclusivity period of 12 years - meaning that the FDA would have to wait 12 years after a biotech drug has hit the market before approving a follow-on version. The generic drug industry, represented by the Generic Pharmaceutical Association, as well as several consumer and patient advocacy groups, favored a five-year exclusivity period similar to the one used for pharmaceutical drugs" (see here).

(4) The last -- and least important -- item on pharma's wish list for Santa is Much fewer "warning" letters from FDA in 2011. As you may know, the FDA has been sending out more of these letters during Obama's administration. This is nicely summarized in the following chart prepared by EyeOnFDA (see here):

At this rate, the number of warning letters will get back to Clinton-era levels before the next election when a new FDA commissioner may be named by a newly-elected republication president (John Boehner?). Now that the next Congress will have a republican majority, we're likely to see this wish fulfilled as FDA officials are grilled by Senate Committees headed by Republicans.

Not that Santa Claus is a Republican! He surely is a Democrat because he's in favor of entitlement -- all good boys and girls and even pharma companies (good or bad) get gifts!

BTW, there were a couple of write-ins for the list:

"A pipeline in a pear tree" -- I have added this to the official survey voting block.

"Human Genomes Sciences' Lupus Drug, "Benlysta"! We Lupies need this quickly-Unfortunately, I know a woman who may not see Christmas because of the FDA delay now. She's in the hospital on a respirator, because Lupus has attacked her lungs and now kidneys. Please help her Santa!" -- I can't argue with this, which I put in the same category as "increased pipeline."

There's still time to get your vote in here.

P.S. Added "fewer law suits" & "increased pipeline" to pharma's XMAS wish list. What's ur favorite(s)? http://bit.ly/dMcr5M