FDA Matters Blog

Bold Discussions: Possible New Approval Pathways for Breakthrough Drugs

November 14th, 2011

For discussion purposes, let’s assume that there is a broad consensus that patients would benefit if new drugs and devices could get to the US market sooner. Current market barriers can be fearsome: long timeframes, high cost and regulatory uncertainty. How can we fix this problem? What costs and risks are involved in getting products to patients faster?

These are old questions, renewed this year by the Biotechnology Industry Organization’s (BIO) proposal to create a “progressive approval” process. This is controversial, but also worthy of widespread discussion. FDA Matters finds itself interested and open-minded about ways to permit earlier market-access if patients will benefit and the safety risk minimized.

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By Whose Standards: FDA’s Identity Crisis and the Level Playing Field

November 7th, 2011

FDA advances public health, protects consumers, regulates products and is an important force in our national economy. Now, FDA is being challenged by Congress and the President to justify itself as a positive force in the advancement of American innovation and as a contributor to US competitiveness.

This is precipitating an identity crisis at FDA. The agency is constantly establishing new standards (and revising old ones) that will protect consumers and bring new therapies to patients. Now it must also consider whether it is unduly impeding American industry. As this forces FDA to rethink who it is and what it stands for, FDA Matters believes a different FDA will emerge.

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In Praise of Predictability: A Virtue Revisited

October 24th, 2011

More than two years ago, FDA Matters suggested that one of FDA Commissioner Hamburg’s goals would be making it easier for stakeholders to anticipate agency actions. I was looking beyond transparency (see what FDA is doing and has done). I hoped the agency would focus on the larger virtue of predictability (being able to anticipate FDA’s standards and actions).

The task has proven larger than I imagined and the volume of issues facing the agency has made progress hard. However, the agency has taken many steps forward, even as it has been pushed backward on a number of occasions. Is the glass half empty or half full?

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A Salmon on Every Plate

October 17th, 2011

President Herbert Hoover supposedly promised Americans “a chicken in every pot” during his 1928 campaign. Chicken was an expensive delicacy then, so his message was about raising living standards, not ending hunger. Today, chicken is a low-cost source of protein and a mainstay of the American diet.

FDA Matters hopes that salmon (and other fish) will also become sources of low-cost protein over the next two decades. FDA is nearing the end of a long regulatory process, the outcome of which could be approval of a faster growing genetically-engineered Atlantic salmon. FDA must overcome opposition from environmental groups…and politicians and companies trying to protect the market for Pacific salmon.

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Should Money Have a Seat at the FDA Table?

October 11th, 2011

FDA’s traditional stakeholders are patients, consumers, health professionals, and industry. Add Congress, media and other government agencies and you have the full set of FDA audiences. What they all have in common: a commitment to the public and individual health of Americans.

While FDA’s focus is health and safety, almost every decision has economic consequences. Money is never far from the surface. Yet, to my knowledge, Wall Street has never been treated as a stakeholder or an audience of FDA. Now a variant has emerged: organized efforts by venture capitalists (VC) to affect how FDA evaluates drugs, biologics and devices.

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FDA Should Consider Cost in Some Decisions

October 3rd, 2011

FDA decides whether drugs, biologics and medical devices are safe and effective and can be marketed legally in the United States. The agency analyzes risk-benefit, but never cost. In contrast, public and private insurers, along with physicians and pharmacists, have the responsibility for cost-benefit decisionmaking.

FDA Matters has always felt quite strongly that this was the right way to allocate roles. Safety and efficacy determinations are difficult enough without weighing cost, so keeping a barrier between them makes sense. Two events this past week have left me wondering whether there are certain limited circumstances when FDA should be able to take product cost into consideration.

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Can FDA Survive the Next Round of User Fee Legislation?

September 25th, 2011

If FDA is to have sufficient money to operate in fiscal year 2013 (and thereafter), drug and device user fee legislation must pass Congress next Spring. That is the immovable object of the agency’s future. To pass legislation, Congress will need to plow through dozens of amendments touching every aspect of FDA and the industries it regulates. This is the irresistible force of Congress.

What happens when this irresistible force meets this immovable object? Something will need to give. FDA Matters hopes it will not be FDA’s ability to carry out its mission.

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FDA and Things that Might Go Bump in the Night

September 18th, 2011

FDA’s everyday business requires balancing risk and benefit as these might apply to a particular medical product or a new food. Occasionally, FDA is faced with a much larger responsibility: judging a breakthrough technology that could bring great benefit or great sorrow to humankind. Who can confidently know in advance which it will be?

Still, FDA must decide. If they say “yes,” whole new industries and benefit may be created for patients and consumers. Or, the world and humankind may be subject to devastation. Today, the agency is faced with just such challenges in dealing with nanotechnology, genetically-engineered (GE) animals, and synthetic biology.

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FDA’s Busy Summer of 2011

September 6th, 2011

Once upon a time, Washington slowed a little over the summer. Those days are long gone…and this was a particularly busy summer. Congress went down to the deadline on the debt limit/deficit reduction legislation, then left town for August. There was a continuous stream of FDA headlines in June, July and August.

FDA Matters focused on a number of the most pressing issues: post-market safety and surveillance; barriers and opportunities for increased drug discovery and approvals; the rising tide of imports; prospects for biosimilars and medical devices; FDA funding; and various crises facing the agency.

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FAQ: How Biosimilars Will Transform the Marketplace

August 21st, 2011

FDA Matters thinks biosimilars will be a huge success. FDA-approved products similar to off-patent biologics (“biosimilars”) will be available in the US by 2014 or 2015, with more added each year. There will eventually be price competition in the range of 20% to 40% discounts. Biosimilars will be used in most health care settings with most prescribers using them at least some of the time.

Much of the current negativity about biosimilars is fed by a mismatch of expectations: the Biologics Price Competition and Innovation Act (BPCIA) is barely 18 months old, while the transformation of the marketplace will take a decade or longer.

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