Tuesday, April 17, 2007

Another Drug Trade Group Opposes Legislation on Biogenerics

Today, yet another follow-up to the ongoing coverage I have given to the issue of legislation to support the introduction of generic insulin, including my original post, a follow-up based on NYT coverage, the news that legislators had finally introduced a bill that would force the FDA to permit generic biopharmaceuticals where patents had already expired, a few relevant follow-ups, including a story that a coalition of businesses' expressed their support for the bill in Congressional testimony, another story that outlined the estimated savings that generic insulin could have on the nation's healthcare budget, and finally, a story that the FDA believes that simple generic biologics like insulin may require less data for approval.

Today, a story was published about The Pharmaceutical Research and Manufacturers of America (PhRMA), which is a trade group representing the country's pharmaceutical research and biotechnology companies (including Eli Lilly and Company, Sanofi-Aventis and Novo Nordisk) which was not surprisingly, vehemently opposed to pending legislation that would enable generic biopharmaceutical medicines. The reason is they want to protect the perpetual monopoly their products now enjoy, something which most other medicines enjoy only for limited durations under Federal law. They join the Biotechnology Industry Organization (BIO), making similarly weak claims in order to protect their monopoly. The only problem is that PhRMA's claims are, at best, gross misrepresentations of the truth, if not outright lies. Both industry trade groups have opposition from AARP (formerly known as the American Association of Retired Persons), which is an extremely influential organization in legislative matters. The full story follows below, and you will note that I have added a few "editor notes" throughout the article designed to call attention to issues I believe are relevant to PhRMA's statements.

Let me go on the record as saying, the brand-name drug industry (sometimes referred to as big Pharma) has been treated very, very well in recent years, often at the expense of U.S. taxpayers. Don't expect to stop this, at best, you may be able to delay this legislation. Big Pharma will ultimately fail in stopping a train that has already left the station, as generic biologics WILL ultimately emerge. The real question is whether it will be done with big Pharma's cooperation and therefore in a way that pleases them, or whether it will be done against what is ultimately in the best interests of society as a whole (and therefore in a manner that works against big Pharma). Right now, the ball is in their court, and it looks like big Pharma wants to play dirty. Not a wise move.

Follow-On Biologic Pathway Bill Could Harm Patients, PhRMA Says
By Emily Ethridge for FDA News
April 18, 2007

PhRMA voiced opposition to proposed legislation that would create a pathway for the FDA to approve follow-on biologics because it will not ensure patient safety and will hinder innovation, the group said. While PhRMA does support a regulatory pathway for the products, the proposed bill does not ensure the best process for the FDA or consumers, the group added.

The "Access to Life-Saving Medicine Act" (S.623 and H.R.1038) does not require clinical trials to prove the safety and efficacy of follow-on biologics, PhRMA Senior Vice President Caroline Loew said. The trials are necessary because even minor differences between follow-on biologics and the brand versions would affect patients, she added. [Editor notes: The bill would give the FDA authority to decide on a case-by-case basis what additional clinical information is required before approval will be granted. Also, if PhRMA's statement is to be credible, then PhRMA is also obliged to support legislation mandating that its members must conduct additional clinical trials at their own expense in order to change their own manufacturing processes, something that the FDA has has not required of the industry previously.] The proposed bill would deny the FDA the authority to determine how to monitor an approved follow-on biologic, Loew said. [Editor note: Is this not what the FDA's "Good Manufacturing Practices" are designed to address?]

It would also allow for the replacement of a follow-on biologic with a similar product that could have a different make-up, Loew said. Physicians would not know if the drug they prescribed was that specific product or a similar one that could have different effects, putting patients in danger, according to Loew. [Editor note: This statement is absolutely false. On March 15, 2007, the head of the FDA, Dr. Andrew von Eschenbach said that copycat versions of biotech drugs may be relegated to a status below that of generic versions of traditional chemical drugs, meaning they would be considered only "similar" to brand-name drugs. The FDA commissioner later told The Associated Press that would mean knockoffs would not be interchangeable, or able to be substituted.]

Loew called the Express Scripts' claim that the regulatory pathway will save money "completely wrong." It is based on "unrealistic assumptions, outdated patient information, basic arithmetic errors and a failure to account for existing competition," she said. She refuted the main assumption that the market for follow-on biologics will match the market for small-molecule generic drugs.

The proposed legislation could also hinder pharmaceutical companies from doing innovative work, Loew added. Congress must consider how the proposed follow-on biologic legislation may affect companies' incentives to create new drugs, which is time-consuming, costly and risky, she said. [Editor note: If this statement is true, how does one explain the continued investment into small-molecule drugs, which already have generic competition?] A recent study estimated the average cost of developing a new therapeutic biotechnology product is more than $1.2 billion.

The House Oversight and Reform Committee recently heard a debate on the best way for the FDA to approve follow-on biologics. Lawmakers previously said the bill may be attached to the new version of the Prescription Drug User Fee Act, and PhRMA CEO Billy Tauzin has expressed his concern that it would weaken the act.


Anonymous said...

Have you ever sent an inquiry to the biologics division of the FDA regarding insulin? Isn’t interesting how quickly you are transferred AWAY from the biologics unit? The trade group PhRMA, which represents the rDNA insulin/analog manufacturers would like you to believe that insulin is covered by this division of the FDA which regulates biologics in the medical community. rDNA insulin and all of new, patented rDNA analogs have NEVER been considered by the FDA as anything more than a small-molecule drug. In other words, human insulin and the insulin analogs have never undergone bioequivalency testing, comparing them to natural insulin, including animal and cadaver forms. The PhRMA lobby group opposes ANY legislation which would allow generic insulin “biologics,” even if THEY (generics) were to be regulated under the guidelines of the new “biologics” division within the FDA. PhRMA senior vice president Carol Loew expressed the opinion that follow-on generic biologics could endanger patients because small changes in the hormone molecule could result in safety and efficacy issues of the generic biologics. The question should be asked of PhRMA, “Why shouldn’t ALL insulins be retested under new biologic guidelines and efficacy comparisons made for all products?

FDA biologics overseers should set up standards and guidelines for batch testing these (all) insulin products since their manufacturing technology is much more critical in end-product identity/replication than in, for instance, products labeled “aspirin” that roll off a conveyor belt. Currently there are no batch testing requirements for insulin products.

rDNA insulin was the first genetically-engineered product to gain FDA approval. Because it was NEW, there were no guidelines in place to address issues that continue to present themselves. By remaining quiet, and allowing the belief that insulin is tightly scrutinized under biologic guidelines, the insulin manufacturers have escaped compliance with more stringent regulations that have been enacted SINCE its introduction. If the pot wants to call the kettle black—let’s demand that the whole damn act get cleaned up. Let’s see just how eager the present manufacturers are to stand behind their products and subject them to both efficacy and safety evaluations, using as comparators the old, natural products that had an 80+ year record?


Scott S said...

I agree completely!