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Pharmaceutical Policy

Thursday, May 28, 2015. The 2st Century Cures Act: Patient Experience in Drug Approval. On Thursday, May 19, 2015, the Energy and Commerce Committee of the House of Representatives voted 51 to 0 to approve the 21. Section 2001 of the Curs Act consists of two subsections, currently denominated (x) and (y). Section 2001 would appear to require very little change to the current approach of the FDA to drug approval. It is that difficulty that may be the objective of the much more interesting Subsection (y).

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Pharmaceutical Policy | pharmaceuticalpolicy.blogspot.com Reviews

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Thursday, May 28, 2015. The 2st Century Cures Act: Patient Experience in Drug Approval. On Thursday, May 19, 2015, the Energy and Commerce Committee of the House of Representatives voted 51 to 0 to approve the 21. Section 2001 of the Curs Act consists of two subsections, currently denominated (x) and (y). Section 2001 would appear to require very little change to the current approach of the FDA to drug approval. It is that difficulty that may be the objective of the much more interesting Subsection (y).

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Pharmaceutical Policy | pharmaceuticalpolicy.blogspot.com Reviews

https://pharmaceuticalpolicy.blogspot.com

Thursday, May 28, 2015. The 2st Century Cures Act: Patient Experience in Drug Approval. On Thursday, May 19, 2015, the Energy and Commerce Committee of the House of Representatives voted 51 to 0 to approve the 21. Section 2001 of the Curs Act consists of two subsections, currently denominated (x) and (y). Section 2001 would appear to require very little change to the current approach of the FDA to drug approval. It is that difficulty that may be the objective of the much more interesting Subsection (y).

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pharmaceuticalpolicy.blogspot.com

1

Pharmaceutical Policy: What the Market Will Bear: Pricing Pressures and Pharmaceutical Value

http://www.pharmaceuticalpolicy.blogspot.com/2014/10/what-market-will-bear-pricing-pressures.html

Thursday, October 16, 2014. What the Market Will Bear: Pricing Pressures and Pharmaceutical Value. Until recently, the high prices of drugs seemed to be something like the weather—something people complained a lot about, but about which nothing could be done. That may be changing. I think the push-back on drug pricing is reaching new levels and both the pharmaceutical industry and its chief lobbying group, PhRMA, are showing concern and taking action. And in this article. And in this video. One of the mo...

2

Pharmaceutical Policy: February 2014

http://www.pharmaceuticalpolicy.blogspot.com/2014_02_01_archive.html

Friday, February 21, 2014. The FDA's proposed rule changes for generic pharmaceutical labels and the GPhA response. Following the Courts decision in. Pliva Inc. v. Mensing. The proposed rule is intended to remove the restrictions on generic drug labeling that lead the. Majority to rule that it was impossible for a generic drug company to comply with a state courts determination that generic drug was unreasonably dangerous because the label failed to adequately warn doctors and patients of the drugs risks:.

3

Pharmaceutical Policy: Profits, Ebola, and Biodefense-- Common Ground for the New Congress

http://www.pharmaceuticalpolicy.blogspot.com/2014/11/profits-ebola-and-biodefense-common.html

Thursday, November 13, 2014. Profits, Ebola, and Biodefense- Common Ground for the New Congress. In my post of November 6, 2014, I linked to an interesting BBC story. That pointed out that pharmaceutical companies are highly profitable in comparison with other industries and that pharmaceutical companies generally spend more on marketing than on research and development. In the case of Pfizer 72% more and in the case of Novartis 47% more). The New York Times. But then had gone undeveloped for ten years.

4

Pharmaceutical Policy: The Need For Publicly Funded Trials To Get Unbiased Comparative Effectiveness Data

http://www.pharmaceuticalpolicy.blogspot.com/2015/02/the-need-for-publicly-funded-trials-to_20.html

Friday, February 20, 2015. The Need For Publicly Funded Trials To Get Unbiased Comparative Effectiveness Data. Originally Posted on Health Affairs. By Robert Bohrer On February 20, 2015 http:/ healthaffairs.org/blog/2015/02/20/the-need-for-publicly-funded-trials-to-get-unbiased-comparative-effectiveness-data/. Comparative effectiveness research was one of the hotly debated components. Than they do on research and development. The need for a marketing edge can also drive drug development. Gazyva and other...

5

Pharmaceutical Policy: December 2014

http://www.pharmaceuticalpolicy.blogspot.com/2014_12_01_archive.html

Sunday, December 7, 2014. Interesting Developments in November. I will be commenting soon on developments related to pharmaceutical patents and their significance for personalized medicine, but in this post I am briefly describing several interesting news items and articles from various media sources, and I am attaching links to the stories and articles. Jonathan Darrow has written a great article entitled Pharmaceutical Gatekeepers. In the Indiana Law Review. In the November 27. Brian L. Strom et al.

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pharmaceuticalpolicy.info

Pharmaceutical Policy | Pharmaceutical Pricing– The Story That Just Keeps Going

http://pharmaceuticalpolicy.info/pharmaceutical-pricing-the-story-that-just-keeps-going

Blog by Professor Robert A. Bohrer. July 23, 2014. Pharmaceutical Pricing– The Story That Just Keeps Going. 2274 billion in sales in just the first quarter of 2014. However, the backlash has been equally huge. In a rare display of bipartisanship in Washington, Senator Ron Wyden (D.-Ore), the Chair of the Senate Finance Committee and Senator Chuck Grassley (R.-Iowa), the Ranking Member of the Finance Committee, sent a demand. Which featured a post entitled Sovaldi: A Poster Child for Predatory Pricing.

pharmaceuticalpolicy.info

Pharmaceutical Policy | Archives | 2014 | May

http://pharmaceuticalpolicy.info/2014/05

Blog by Professor Robert A. Bohrer. Monthly Archives: May 2014. Similar Drugs, Different Doses: A Serious Problem for Comparative Efficacy. Sorry- this post is temporarily unavailable. A Few Thoughts About Biosimilars. In Samsung’s other biologics effort, Samsung Biologics will work with Quintiles, the global contract research organization (CRO), to develop biologics for Roche and Bristol Meyers Squibb. Continue reading →. Next Page ». Pradaxa and Drug Safety: Product Liability Played a Role. July 8, 2014.

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Pharmaceutical Policy | Archives | 2011 | July

http://pharmaceuticalpolicy.info/2011/07

Blog by Professor Robert A. Bohrer. Monthly Archives: July 2011. What Is Pharmaceutical Policy and What Is Its Goal? Pradaxa and Drug Safety: Product Liability Played a Role. July 31, 2014. Pharmaceutical Pricing– The Story That Just Keeps Going. July 23, 2014. The Good, the Bad, and the Ugly: Developments in the Intersection of Patents and Pharmaceutical Policy. July 16, 2014. The End May Not Be Near But The Future Is Not Looking Very Good. July 8, 2014. Reflections on BIO 2014: From FIPCOs to VIDDCOs.

pharmaceuticalpolicy.info

Pharmaceutical Policy | Category | Global

http://pharmaceuticalpolicy.info/category/global

Blog by Professor Robert A. Bohrer. July 30, 2011. What Is Pharmaceutical Policy and What Is Its Goal? Pradaxa and Drug Safety: Product Liability Played a Role. July 31, 2014. Pharmaceutical Pricing– The Story That Just Keeps Going. July 23, 2014. The Good, the Bad, and the Ugly: Developments in the Intersection of Patents and Pharmaceutical Policy. July 16, 2014. The End May Not Be Near But The Future Is Not Looking Very Good. July 8, 2014. Reflections on BIO 2014: From FIPCOs to VIDDCOs. July 1, 2014.

pharmaceuticalpolicy.info

Pharmaceutical Policy | blog by Professor Robert A. Bohrer

http://pharmaceuticalpolicy.info/page/2

Blog by Professor Robert A. Bohrer. July 16, 2014. The Good, the Bad, and the Ugly: Developments in the Intersection of Patents and Pharmaceutical Policy. This week I am focusing on patent law, which is one of the more arcane and technical areas of pharmaceutical policy. A recent major decision by the Court of Appeals for the Federal Circuit (CAFC) in. Bristol-Myers Squibb v. Teva Pharmaceuticals. July 8, 2014. The End May Not Be Near But The Future Is Not Looking Very Good. Laquo; Previous Page. Reflect...

pharmaceuticalpolicy.info

Pharmaceutical Policy | blog by Professor Robert A. Bohrer

http://pharmaceuticalpolicy.info/page/12

Blog by Professor Robert A. Bohrer. March 15, 2014. An Estimate of Pharmaceutical Industry Product Liability Costs. Continue reading →. July 30, 2011. What Is Pharmaceutical Policy and What Is Its Goal? Laquo; Previous Page. Pradaxa and Drug Safety: Product Liability Played a Role. July 31, 2014. Pharmaceutical Pricing– The Story That Just Keeps Going. July 23, 2014. The Good, the Bad, and the Ugly: Developments in the Intersection of Patents and Pharmaceutical Policy. July 16, 2014. July 8, 2014.

pharmaceuticalpolicy.info

Pharmaceutical Policy | blog by Professor Robert A. Bohrer

http://pharmaceuticalpolicy.info/page/3

Blog by Professor Robert A. Bohrer. July 1, 2014. Reflections on BIO 2014: From FIPCOs to VIDDCOs. Continue reading →. June 24, 2014. FTC Files Brief in Mylan v. Celgene. Let us hope the FTC’s position prevails in this case. Laquo; Previous Page. Next Page ». Pradaxa and Drug Safety: Product Liability Played a Role. July 31, 2014. Pharmaceutical Pricing– The Story That Just Keeps Going. July 23, 2014. The Good, the Bad, and the Ugly: Developments in the Intersection of Patents and Pharmaceutical Policy.

pharmaceuticalpolicy.info

Pharmaceutical Policy | Archives | 2014 | June

http://pharmaceuticalpolicy.info/2014/06

Blog by Professor Robert A. Bohrer. Monthly Archives: June 2014. FTC Files Brief in Mylan v. Celgene. Let us hope the FTC’s position prevails in this case. Andrew Pollock’s NY Times Article on Increasing Pressure on Drug Prices: Do Health Insurers Now Have Skin in the Game? In this post I will speculate very briefly about an important new development reported by Andrew Pollock of The New York Times. The subject of Pollock’s article. PBMs) to use their formularies to reduce insurers’ prescription dr...

pharmaceuticalpolicy.info

Pharmaceutical Policy | Author | Robert Bohrer

http://pharmaceuticalpolicy.info/author/witek

Blog by Professor Robert A. Bohrer. Pradaxa and Drug Safety: Product Liability Played a Role. This week’s post is about the problem of product liability in pharmaceutical policy, an issue that I have not discussed since my first posts. Concerns over data in key dabigatran trial. Accompanying the article was a feature editorial with the even more attention-grabbing title:. Dabigatran: how the drug company withheld important analyses. Continue reading →. 2274 billion in sales in just the first quarter of 2...

pharmaceuticalpolicy.info

Pharmaceutical Policy | Archives | 2014 | March

http://pharmaceuticalpolicy.info/2014/03

Blog by Professor Robert A. Bohrer. Monthly Archives: March 2014. Darrow, Avorn, and Kesselheim on the new FDA category of “Breakthrough” Drugs. This weeks New England Journal of Medicine includes a terrific article by Darrow, Avorn, and Kesselheim:. New FDA Breakthrough-Drug Category- Implications for Patients. Tu, Holman, Mossoff et al. Make a Valuable Contribution to the Often Wildly Inaccurate Discussion of Gene Patents. Association For Molecular Pathology et al. Next Page ». July 31, 2014.

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pharmaceuticalpolicy.blogspot.com

Pharmaceutical Policy

Thursday, May 28, 2015. The 2st Century Cures Act: Patient Experience in Drug Approval. On Thursday, May 19, 2015, the Energy and Commerce Committee of the House of Representatives voted 51 to 0 to approve the 21. Section 2001 of the Curs Act consists of two subsections, currently denominated (x) and (y). Section 2001 would appear to require very little change to the current approach of the FDA to drug approval. It is that difficulty that may be the objective of the much more interesting Subsection (y).

pharmaceuticalpolicy.info

Pharmaceutical Policy | blog by Professor Robert A. Bohrer

Blog by Professor Robert A. Bohrer. July 30, 2011. What Is Pharmaceutical Policy and What Is Its Goal? July 31, 2014. Pradaxa and Drug Safety: Product Liability Played a Role. This week’s post is about the problem of product liability in pharmaceutical policy, an issue that I have not discussed since my first posts. Warfarin) which is used for the same purpose but has a different mechanism of action and requires individual dosing and monitoring. Pradaxa has been the subject of very interesting news t...

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