DOMINIC COYLE
Blockbuster drugs coming off patent will knock a major hole in our export figures and tax revenues
PHARMACEUTICALS HAVE been a driving force for Ireland’s export success in recent years. Even through the darkest days of our financial collapse and recession, the sector, dominated by the large multinational players, continued to deliver export growth and a glimmer of hope of economic recovery.
However, the most recent trade figures point to a looming problem for the Government. Reporting a 9 per cent fall in exports in December, the Central Statistics Office was unusually frank and detailed in stating that “a substantial part of the decline in the value of exports was due to a high value product in the chemicals and related products sector coming off patent”.
The drug is Lipitor, Pfizer’s blockbuster cholesterol lowering therapy and the world’s best-selling drug in recent years, accounting for revenues of $10.7 billion in 2010. Pfizer’s Cork plant produces 100 per cent of the company’s global requirements for the active pharmaceutical ingredient in the drug and a significant portion of the finished tablets.
Coming off patent will knock a major hole in the future revenues Pfizer can expect to get from the drug as generic competition kicks in. As a rule, loss of patent protection can hit the value of sales by anything between 40 and 70 per cent over time – and not much time at that.
For Ireland, the concern in the December figures was that, for now, generic competition to Lipitor is limited. If that was enough to skew the export figures so dramatically, the worry is what damage future, more intense competition will do to our trade balance.
And Lipitor is just one of a number of key drugs in which Ireland has a commercial interest and which are coming off patent. Chris van Egeraat, a lecturer in economic geography at NUI Maynooth, says seven of the 10 largest-selling drugs worldwide which are losing patent protection are currently produced in Ireland. They include the best-selling drug worldwide in 2010 after Lipitor; Sanofi/Bristol Myers Squibb’s blood clotting treatment Plavix, with sales of $9.43 billion. It comes off patent in May.
Globally, it is estimated that as much as $100 billion in sales will be lost to drug companies between 2009 and 2014 as a result of drugs coming off patent. Expected pipeline delivery in terms of market revenue over the same time amounts to about $30 billion, Dr van Egeraat says.
While he doesn’t expect the loss of patents to lead to huge imminent job losses, it does highlight the ambition of the Government’s new Action Plan for Jobs, which has targeted the health and life sciences sector for significant growth in the coming years to help reach the Government’s 100,000 job target.
However, loss of market sales will clearly impact on trade figures and tax revenues. The Irish Pharmaceutical Healthcare Association (IPHA notes that the pharmaceuticals sector accounts for roughly half of all exports and is the largest contributor to corporation tax, accounting for roughly 50 per cent of the ˆ3.5 billion collected last year.
In employment terms, IPHA president and Pfizer country manager David Gallagher says that about 25,000 people are employed directly in the industry, with a roughly similar number working in related sectors. He notes that pharmaceuticals has been more resilient than other sectors of the economy during recent “economically challenging times”.
The message is pointed, especially at a time when the sector is locked in a dispute with the Government over access to market for its new drugs and the contribution it can make to savings in the health budget sought by the State.
David Gallagher noted recently that an increasing number of innovative medicines are currently not being reimbursed by the Department of Health, despite being approved by regulators and meeting health technology assessments.
He recently accused the department of acting in bad faith by refusing to approve drugs for reimbursement as provided for under the industry’s current pricing agreement with the Department, even though the industry had delivered savings of about ˆ540 million over the past five years, a figure he says equates to a 20 per cent cut.
Even before the latest row, the IPHA said the delay between approval and market access had jumped by over 50 per cent to 157 days in recent years, and only 64 per cent of drugs that received market authorisation in the EU between 2007 and 2009 were made available to patients here.
Matt Moran, director of Ibec group PharmaChem Ireland, said Government policy “needs to urgently recognise the very serious challenges facing the industry”.
“A number of blockbuster drugs are coming off patent and healthcare spending in Ireland has been cut by ˆ600 million in the last five years,” he said. “The future success of the sector must not be taken for granted.”
In a speech last year, Gallagher said further price concessions were “simply untenable”, citing preliminary 2011 figures pointing to a 5.2 per cent decline in the value of the Irish market. “There is a limit to the amount which can be taken out of a market without its effective operation and employment being jeopardised,” he said.
Ireland is not alone. The commercial prospects for big pharma were also thrown into sharp focus with a report on the UK’s pharmaceuticals price regulation scheme, which reported collective industry losses of ?142 million in 2009 despite rising sales.
For its part, the Department of Health needs to find cuts in its budget. In a recent report on pharma pricing, the Economic and Social Research Institute (ESRI said that drug costs account for about 17.5 per cent of public health expenditure in Ireland, up from 14 per cent in 2000.
In 2009, the ESRI says, spending per head of population in Ireland on pharmaceuticals was “amongst the highest in the OECD”.
It is understood the Department of Health is targeting a saving of about ˆ112 million from the drugs bill – either in terms of pricing and access for new medicines or pricing of generics.
The ESRI report recommended a number of approaches. These included pricing drugs on the basis of the lowest cost in a basket of European markets rather than the average, and more regular price updates to capture the impact of falling prices earlier.
The industry says that, despite the small physical size of the Irish market, such a move would be negative in two ways. First, Ireland is itself a component of pricing baskets in eight other larger EU markets. A “match the lowest” price here will inevitably further eat into prices in other more important markets.
Secondly, the industry points to Ireland’s importance as a base of operations for most of the main players in the sector. An increasingly adversarial approach with the State will only damage the prospects for future investment, they say, with one industry source saying the recent approach of the department to market access for new drugs was creating a very poor impression in a number of important boardrooms State-side.
The seriousness with which the pharmaceutical sector views the current price negotiations in Ireland – where eight of the top 10 global players have operations – is highlighted by the engagement of some of the industry’s leading figures with the Government.
The chief executive of one major global player has made a point of briefly visiting Ireland next week. The message in his first visit to the State will not be lost on ministers. The following week, leading executives from another top 10 drug manufacturers gather in Dublin for a meeting at which the attitude of the State to the sector is certain to figure.
On the Government’s side, there is concern too at any adverse impact on such a major employer and contributor to the exchequer. Taoiseach Enda Kenny has recently engaged directly in private meetings with top industry figures here to assure them of the Government’s support despite the ongoing budgetary squeeze.
For their part, the drug companies say that current pricing pressures are restricting innovations. Without adequate compensation, they say, companies simply will not be able to invest in new products given the costs involved and the risk of failure.
This isn’t unique to Ireland. Reporting annual results earlier this month, Bayer chief executive Marijn Dekkers expressed concern “about the side-effects” of health service reforms taking place around the world “because the money we earn from today’s medicines pays for the development of tomorrow’s medicines”.
Pointing to the ˆ2 billion research and development cost of Xarelto, a new drug developed with Johnson Johnson to prevent blood clotting, he said: “We need innovative pharmaceuticals more than ever, because so many known diseases still cannot be treated adequately, or at all, with medicines.”
But that’s part of the problem for the major pharmaceutical companies. Many of the easy treatment areas are now well catered for. A good portion of the drugs that do so are shortly coming off patent and are easily accessible to generic competition.
The opportunities of the future lie in increasingly niche conditions or very high risk areas such as oncology and, especially, neurology. Added to this is the move to biologics and the trend towards more personalised medicines.
The challenge is evident in the fact that, last year, the US drug regulator, the Food and Drug Administration, licensed just a handful of new pharmaceutical therapies. Getting this more select group of drugs to as many markets as possible is increasingly critical for big pharma.
The age of the blockbuster is fading, along with the fat profit margins it offered. That presents major issues for the sector. Over time, through consolidation and acquisition, they have grown into massive unwieldy entities with poorly directed research failing to deliver sufficient pipeline.
In recent years, much effort has been devoted to streamlining operations and increasing productivity, especially on the research side. Thousands of jobs have been shed worldwide, and greater emphasis placed on outsourcing much of the early-stage RD work.
A case in point is Elan’s prospective Alzheimer’s treatment bapineuzumab. Originally developed by the company in association with Wyeth, it is now controlled by Pfizer (which acquired Wyeth to fill a perceived weakness in its biopharmaceuticals operations and Johnson Johnson, which bought an 18.4 per cent stake in Elan in 2009 in a deal valued at $1 billion. Its interest was driven largely by the Irish company’s pipeline – particularly bapineuzumab which is seen as one of the more promising candidates to address a disease with limited treatment options at present and which reports critical Phase III trial data later this year.
The second focus is on developing new markets. But that presents its own problems, not least with business practices that have reflected poorly on the industry.
Several of the largest drug companies have been implicated in an ongoing legal action in Serbia in which a group of 10 doctors and drug company officials were charged with taking, or offering, more than ˆ500,000 in bribes to use specific products. While all deny guilt in this case, an examination of US Securities and Exchange Commission (SEC filings by the world’s top 10 drug companies has found that eight of them recently warned of potential costs related to charges of corruption in overseas markets.
Life is unlikely to get any easier for the sector over the coming two or three years. That raises the stakes in the ongoing price negotiations. The new accord was due to come into force yesterday and, as the leaked Commission assessment this week illustrated, pressure on the Government to deliver the necessary savings to ensure their budgetary projections is only likely to intensify.
Continue reading "VP Biden Visiting Latin America Amid Drug Legalization Debate" >
Doctors can still get free samples of medicines, though not football tickets or lunch for their spouses, under a revised code of conduct drafted by a global drug industry trade group.
The new rules clarify the differences between gifts, promotional aids and items such as anatomical models that can be used in medical practice, the
International Federation of Pharmaceutical Manufacturers & Associations said today in a statement. The federation’s member companies will be required to adopt the new guidelines and provide related training to their 1.3 million employees, the group said.
The code may help curb legal expenses related to marketing, particularly in the U.S., where
GlaxoSmithKline Plc (GSK last year agreed to pay $3 billion to resolve criminal and civil investigations and other matters.
Pfizer Inc. (PFE and
Eli Lilly & Co. (LLY each paid more than $1 billion to settle marketing allegations in 2009.
Novartis AG (NOVN and
AstraZeneca Plc (AZN are among drugmakers that in the past year have disclosed U.S. subpoenas seeking information on the selling of certain products.
“The new code provides a framework for the industry to act with integrity and build trust,” AstraZeneca Chief Executive Officer David Brennan, the federation’s president, said in the statement. “This is not about doing the easy thing, but the right thing.”
Free Samples
Free samples of medicines may be given to doctors who are authorized to prescribe them to patients, the federation said in the code. Companies should avoid extravagant venues for meetings, be transparent in promotional materials, and shouldn’t offer items for the personal benefit of a doctor or nurse, such as gift certificates or concert tickets, according to the guidelines.
“As a general rule, the hospitality provided must not exceed what participants would normally be prepared to pay for themselves,” the federation said in the code. “Companies should not pay any costs associated with individuals accompanying invited health-care professionals.”
The rules don’t address direct-to-consumer advertising, pricing or other trade terms for supplying wholesalers and other commercial customers, or promotion of medical devices, the federation said. Drugmakers that fund patient advocacy groups shouldn’t insist on being the sole sponsor of such an organization, and should outline in writing the nature of the financial support, according to the code.
To contact the reporter on this story: Kristen Hallam in London at
khallam@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at
pserafino@bloomberg.net
LONDON, March 1 |
(Reuters - The global pharmaceutical industry is tightening its code of practice in a bid to stamp out bribery and corruption, particularly in emerging markets.LONDON, March 1
The International Federation of Pharmaceutical Manufacturers and Associations said on Thursday it had expanded and strengthened the code to ensure "the highest ethical and professional standards".
FREE GUIDES AND REPORTS FROM DIANOMIADVERTISEMENTBribes paid to foreign doctors and other state employees are shaping up as a major legal liability threat for Big Pharma, which has already forked out billions of dollars to settle mis-selling scandals in the United States.
Johnson & Johnson settled for $78 million with British and U.S. authorities last April, after disclosing payments to doctors in
Greece, Poland and Romania, while Pfizer reached an outline deal in a separate case late last year.
The new IFPMA code extends the rules covering drug company behaviour to also include interactions with medical institutions and patient organisations, as well as healthcare professionals, such as prescribing doctors.
It also makes clearer the dividing line between promotional aid and items of medical utility - which are allowed, and personal and cash gifts - which are not.
Permitted payments for entertainment are being curtailed, although they will still be allowed when interactions with drug firms are of a scientific or educational nature, including events at large medical meetings.
"The new code provides a framework for the industry to act with integrity and build trust," said IFPMA President and AstraZeneca CEO David Brennan. "This is not about doing the easy thing, but the right thing."
The Geneva-based organisation sees a particular role for its expanded code of practice in thinly regulated and smaller emerging markets, where national pharmaceutical organisations may have no presence.
But Tim Reed, director of Health Action International, an Amsterdam-based group that is critical of many industry practices, is not convinced the IFPMA has the teeth to make sure its edicts are implemented on the ground.
In the five years since the publication of the last code, the IFPMA has examined only four complaints against member companies - although more cases have been taken up by national organisations.
"There is a difference between intent and action," Reed said. "When you drill down to what is happening in developing countries, it is clear that it is just not applied. There is a real problem with enforcement because there is no punitive action as a result of transgression." (Editing by
Kate Kelland and
Jodie Ginsberg
Submitted by Brandon Smith from
Alt-Market
Americans Will Need “Black Markets” To Survive
As Americans, we live in two worlds; the world of mainstream fantasy, and the world of day-to-day reality right outside our front doors. One disappears the moment we shut off our television. The other, does not…
When dealing with the economy, it is the foundation blocks that remain when the proverbial house of cards flutters away in the wind, and these basic roots are what we should be most concerned about. While much of what we see in terms of economic news is awash in a sticky gray cloud of disinformation and uneducated opinion, there are still certain constants that we can always rely on to give us a sense of our general financial environment. Two of these constants are supply and demand. Central banks like the private Federal Reserve may have the ability to flood markets with fiat liquidity to skew indexes and stocks, and our government certainly has the ability to interpret employment numbers in such a way as to paint the rosiest picture possible, but ultimately, these entities cannot artificially manipulate the public into a state of demand when they are, for all intents and purposes, dead broke.
In contrast, the establishment does have the ability to make specific demands or necessities illegal to possess, and can even attempt to restrict their supply. Though, in most cases this leads not to the control they seek, but a sudden and sharp loss of regulation through the growth of covert trade. The people need what the people need, and no government, no matter how titanic, can stop them from getting these commodities when demand is strong enough.
This process of removing necessary or desirable items from a trade environment leads inevitably to counter-prohibition often in the form of strict cash transactions, barter markets, or “black markets” as they are normally derided by those in power. The problem for economic totalitarians is that the harder they squeeze the masses, the more intricate the rebellion becomes, especially when all they want is to participate in free markets the way our forefathers intended.
The so called “drug war” is proof positive of the impossibility of locking down a product, especially one that has no moral bearing on the people who are involved in its use. Only when a considerable majority of a populace can be convinced of the inherent immoral nature of an illicit item can its trade finally be squelched. During any attempt to outlaw a form of commerce, a steady stream of informants convinced of their service to the “greater good” is required for success. Dishonorable governments, therefore, do not usually engage in direct confrontation with black markets. Instead, they seek to encourage the public to view trade outside mainstream legal standards as “taboo”. They must condition us to react with guilt or misplaced righteousness in the face of black market activity, and associate its conduct as dangerous and destructive to the community, turning citizens into an appendage of the bureaucratic eye.
But, what happens when black markets, due to calamity, become a pillar of survival for a society? What happens when the mainstream economy no longer meets the available demand? What happens when this condition has been deliberately engineered by the power structure to hasten cultural desperation and dependence?
In this event, black markets not only sustain a nation through times of weakness, but they also become a form of revolution; a method for fighting back against the centralization of oppressive oligarchies and diminishing their ability to bottleneck important resources. Black markets are a means of fighting back, and are as important as any weapon in the battle for liberty. Here are just a few reasons why such organizational actions may be required in the near future…
The Mainstream Economy Is Slowly Killing Us
There are, unfortunately, some Americans out there who have not caught on yet to the grave circumstances in which we live. Obviously, the stock market seems to have nearly recovered from its epic collapse in 2008 and 2009, and employment, according to the Labor Department, is on the mend. The numbers say it all, right? Wrong! The numbers say very little, especially when they are a product of “creative mathematics”.
Despite the extreme spike in the Dow Jones since 2010, and all the talk of recovery, what the mainstream rarely mentions are the details surrounding this miraculous return from the dead for stocks.
One of the most important factors to consider when gauging the health of the markets is “volume”; the amount of shares being traded and the amount of investors active on any given business day. Since the very beginning of the Dow’s meteoric rise, the markets have been stricken with undeniably low volume interspersed with all too brief moments of activity. In fact, this past January recorded the lowest NYSE volume since 1999:
http://www.bloomberg.com/news/2012-01-23/stock-trading-is-lowest-in-u-s-since-2008.html
Market volume has tumbled over 20% since last year, and is down over 50% from 2008 when the debt implosion began:
http://blogs.wsj.com/marketbeat/2012/02/24/trading-volume-anemic-this-year/
So then, if trade is sinking, why has the Dow jumped to nearly 13,000? Low volume is the key. In a low volume market, less individual investors are present to counteract the buying and selling of larger players, like international banks. When this happens, the big boys are able to trigger market spikes, or market drops, literally at will. Add to this the high probability that much of the stimulus that the Federal Reserve has regurgitated into the ether probably ended up in the coffers of corporate banks which then used the funny money to snap up equities, and presto! Instant market rally! But, a rally that is illusory and unstable.
Improving employment numbers are yet another financial hologram. As most of us in the Liberty Movement are well aware, the Labor Department does not calculate true unemployment in the U.S. Instead, it merely calculates those people who currently receive unemployment benefits. Once a person hits the extension limit (99 weeks in many states on his benefits, he is removed from the rolls, and is no longer counted in the “official” unemployment percentage. While Barack Obama and MSM pundits are quick to point out the drop in jobless to 8.3%, what they conveniently fail to mention is that MILLIONS of Americans have been unemployed for so long that they have been removed from the statistics entirely, and this condition is what has caused the primary fall in jobless percentages, not burgeoning business growth.
Roughly 11 million Americans who are jobless have nonetheless been excluded from the statistical government tally because of a loss of benefits:
According to the Congressional Budget Office, over 40% of the currently unemployed have been so for over 6 months. It also points out that America is suffering the worst case of long term unemployment since the Great Depression:
http://www.cbo.gov/sites/default/files/cbofiles/attachments/02-16-Unemployment.pdf
More than 10.5 million people in the U.S. also receive disability payments, which automatically removes them from the unemployment count, making it seem as though jobs are being created, rather than lost:
http://www.foxnews.com/politics/2012/02/19/report-millions-jobless-file-for-disability-when-unemployment-benefits-run-out/
Around 8.2 million Americans only work part time, meaning they work less hours than are generally considered to be necessary for self-support. These people are still counted as “employed” even if they work a few hours a week.
True unemployment, according to John Williams of Shadowstats, is hovering near 23%:
http://www.shadowstats.com/alternate_data/unemployment-charts
Combine these circumstances with the ever weakening dollar, price inflation in foods and other commodities, and rocketing energy costs, and you have an economy that is strangling the life out of the middle-class and the poor in this country. It is only a matter of time before the populace begins searching for alternative means of subsistence, even if that entails “illegal” activities.
Government Cracking Down On Freedom Of Trade
I was recently walking through the parking lot of a grocery store and ran into a group of women huddled intently around the back of a mini-van. One of the women was reaching into a cooler and handing out glass containers filled with milk. I approached to ask if she was selling raw milk, and if so, how much was she charging. Of course, they turned startled and wide eyed as if I had just stumbled upon their secret opium ring. Somehow it had slipped my mind how ferocious the FDA has become when tracking down raw milk producers. The fact that these women were absolutely terrified of being caught with something as innocuous as MILK was disturbing to me. How could we as a society allow this insanity on the part of our government to continue?
That moment reminded me of the utter irrelevance of petty law, as well as the determination of human beings to defy such law.
The Orwellian hammer has been thrust in the face of those who trade in raw milk, organic produce, and herbal supplements, while small businesses are annihilated by government dues and red tape. In the meantime, law enforcement officials have been sent strapped to shut down children’s lemonade stands (no, seriously :
http://www.cbsnews.com/2100-500164_162-20079838.html
Government legislation which would give the FDA jurisdiction over personal gardens has been fielded. Retail gold and silver purchases of over $600 are now tracked and taxed. The IRS even believes it has the right to tax barter exchanges, even though they do not explain how bartered goods could be legally qualified as “income”, or how they can conceive of ever being able to trace such private trade:
http://www.irs.gov/newsroom/article/0,,id=205581,00.html
Want to choose what kind of currency you would like to use to protect your buying power? Not if the Department Of Justice’s Anne Tompkins has anything to say about it. After the railroading of Liberty Dollar founder Bernard von NotHaus, she stated:
“Attempts to undermine the legitimate currency of this country are simply a unique form of domestic terrorism…”
“While these forms of anti-government activities do not involve violence, they are every bit as insidious and represent a clear and present danger to the economic stability of this country,” she added. “We are determined to meet these threats through infiltration, disruption, and dismantling of organizations which seek to challenge the legitimacy of our democratic form of government.”
http://www.fbi.gov/charlotte/press-releases/2011/defendant-convicted-of-minting-his-own-currency
As our economic situation grows increasingly precarious in this country, more and more people will turn towards localized non-corporate, non-mainstream business methods and products. And, the government will no doubt attempt to greatly restrict or tax these alternatives. This mentality is driven in part by their insatiable appetite for money, but mostly, it’s about domination. They do what they do because they fear decentralized markets, and the ability of the citizenry to conceive of choices outside the system. Slaves are not supposed to choose the economy they will participate in…
A “black market” is only a trade dynamic that the government disapproves of, and the government disapproves of most things these days. Frankly, its time to stop worrying about what Washington D.C. consents to. They have unfailingly demonstrated through rhetoric and action that they are not interested in the fiscal or social health of this nation, and so, we must take matters into our own hands.
Black Market Advantages
If the events in EU nations such as Greece, Spain, and Italy are any indication, the U.S., with its massive debt to GDP ratio (real debt includes entitlement programs , is looking at one of two possible scenarios: default, austerity measures, and high taxes, or, hyperinflation, and then default, austerity measures, and high taxes. In the past we have mentioned barter networking and alternative market programs springing up in countries like Greece and Spain allowing the people to cope with the faltering economy. Much of this trade is done away from the watchful eyes of government, simply because they cannot afford the gnashing buffalo-sized bites that bureaucrats would take from their savings in the process. When a government goes rogue, and causes the people harm, the people are in no way obligated to continue supporting that government.
Black markets give the citizenry a means to protest the taxation of a government that no longer represents them. In a country stricken with austerity, these networks allow the public to thrive without having to pay for the mistakes or misdeeds of political officials and corporate swindlers. In a hyperinflationary environment, black markets (or barter markets that have been deemed unlawful , can be used to supplant the imploding fiat currency altogether, and energize community markets that would otherwise be unable to function. Ultimately, black markets feed and clothe the grassroots movement towards economic responsibility, and every man and woman with any sense of independence should rally around this resource with the intention to fight should it ever be threatened.
“Legality” is arbitrary in the face of inherent conscience, or what some call “natural law”. Without arbitrary legality, and unjust and unwarranted regulation, many federal alphabet agencies would not exist, including the FDA, the IRS, the EPA, the BLM, etc. These institutions do not matter. What they say has no meaning. What matters is what is honorable, what is factual, and what is right. Our loyalty, as Americans, is to our principles and our heritage. Beyond that, we don’t owe anyone anything. A black market in one place and time is a legitimate market in another. For now, private localized trade is able to flow with only minor interference, but there will come a day when even the most practical and harmless personal transactions will be visited with administrative reproach and vitriol. Alternative market champions will be accused of “extremism”, and undermining the mainstream economy. We will be vilified as separatists, isolationists, terrorists, and traitors. I believe it will be far more surreal than what we can possibly imagine now.
They are welcome to call us whatever they like. Honestly……who cares? Let the paper pushers do their angry little dance. The goal is freedom; in life, in politics, and in trade. If we do not change how this country does business ourselves, the results will be far more frightening than any government agent at our doorstep, and the costs will be absolute…
FDA Commissioner Margaret Hamburg has announced Elizabeth ("Liz" Dickinson was appointed as the Chief Counsel of FDA, effective March 12, 2012.
The new Chief Counsel has had a long and distinguished career at FDA since she joined the agency in 1994. She has principally served as legal counsel to FDA's Center for Drug Evaluation and Research, providing advice in such key areas as Hatch-Waxman generic drug approvals, pediatric exclusivity and orphan drugs. She has also worked closely with the Department of Justice representing FDA in many court cases. Liz is well respected by both her colleagues at FDA and outside lawyers representing companies in FDA-regulated industries.
Among the imminent issues that Liz will face at FDA include generic drug user fees, drug shortages, and regulations/guidances for the Agency's implementation of new statutes on food safety and tobacco products.
Liz received her B.A. in Economics from the University of Massachusetts, and her J.D. from Northeastern University. She clerked for Judge William B. Bryant at the U.S. District Court for the District of Columbia.
Mark Raza will continue to serve as the Acting Principal Deputy Chief Counsel.
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