critics

Bill could improve funding for small biotechs

Fri, 05 Oct 2007 06:59:55 -0400

In a victory for small biotech, the U.S. House passed a bill that allows small companies to be eligible for federal small-business programs even if they're majority-owned by VC firms. Biotechs can often go for a decade or more before marketing a product, and they rely on investment from VC firms to keep the company going through the early stages of drug development. However, by the time a biotech has a marketed drug, VCs can own a large chunk. This means that the small company isn't eligible for Small Business Innovation Research (SBIR) awards.

The new legislation will lift current restrictions, giving small biotechs access to SBIR awards as long as VC firms own less than half of the company. "Private investment in small business is a good thing and should be encouraged, not discouraged," said Rep. Sam Graves (R-MO), the bill's co-sponsor. However, among other concerns, critics say opening up SBIR awards to more established companies will make competition harder for small start-ups.

- read the Baltimore Business Journal article

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FDA bonuses used to keep regulators in-house

Tue, 17 Jul 2007 06:59:56 -0400

The FDA is handing out $8 million in bonuses as it hopes that a sweetened pot will keep regulators from bolting to the pharma industry. Those bonuses add up to about $5,000 or more for each employee, which the agency says is absolutely critical for retaining experienced personnel. Critics, though, say the agency should be spending more on safety. The FDA has long been one of the biggest users of bonuses in the federal government. Maybe if the news gets around more people in private industry will move into the government.

- here's the AP report on the bonuses

Related Articles:
IOM slams FDA, calls for major reforms. Report
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PDUFA debate highlights drug safety issues

Thu, 05 Jul 2007 00:01:35 -0400

The House is expected to take up PDUFA legislation soon, and that has renewed the debate over the impact of the fees and the possibility of new requirements related to pharmacovigilance. PDUFA, which has to be reauthorized every five years, has been a hot topic of late. Critics maintain that PDUFA has given the drug industry too much influence at the FDA, which is seeking an $87 million boost in the amount of money it brings in from the fees. But The Washington Post notes that the way the legislation is being molded in Congress, reauthorization this year seems highly likely. The industry has been largely satisfied with the way PDUFA, originally passed in 1992, has helped speed the drug review process.

New reports, though, have helped fuel the debate. One study shows that biopharma has profited considerably from faster approval times, but another researcher has linked faster approvals to greater safety troubles. Both of those topics will be front and center in the debate that's coming.

- read the article on PDUFA reauthorization from The Washington Post

Related Articles:
Senate toughens drug safety supervision in PDUFA bill. Report
FDA, drug industry re-negotiate user fees. Report
Congress juggles two crucial drug bills. Report
FDA critics offer data on "cozy" industry ties. Report

It's alive! Team advances work on artificial life

Fri, 29 Jun 2007 00:01:36 -0400

A scientific team led by genomic pioneer Craig Venter has taken an organism and turned it into a different species in what's being billed as the world's first genome transplant. The scientific advance lays the groundwork for creating artificial life forms and demonstrates the ability to implant a set of genetic instructions into an organism. The next phase of this approach will be to create genetic codes on a computer and insert them into organisms, creating new life forms. From a commercial perspective, Venter is looking to create new biofuels that would replace the oil and gas in use today without damaging the environment. Critics, though, say that the work raises the prospect of terrifying new bioweapons--or a disaster sparked by an accident in the lab.

- see the team's release
- here's the report from The Guardian

New rules could relax standards for Phase I drugs

Mon, 06 Nov 2006 19:01:36 -0500

A proposed change in federal regulations would make it possible for universities and biotech companies to make drugs in their own labs for Phase I trials. Under existing rules, universities and biotechs often have to outsource the manufacture of Phase I drugs to specialty manufacturers. That can be prohibitively expensive for small research budgets and a new standard would lower drug development costs. If the rules are relaxed, though, some critics say that the FDA may be opening the door to increasing the safety risks of the volunteers in early-stage trials.

- check out the Triangle Business Journal report on the proposed rule change

Merck review absolves management of misconduct

Wed, 06 Sep 2006 20:01:34 -0400

Merck spent $21 million to commission a review of its actions regarding the Vioxx debacle,and got a 179-page report that absolved its management of any wrongdoing and earned scoffs from a legion of critics. The 20-month, 1,700-page review concluded that the company's senior management acted with integrity and never intended to misguide anyone about Vioxx's safety. Lawyers and their clients who are squaring off against the company aren't likely to buy into that conclusion.

- read the Los Angeles Times report

FDA to regulate new generation of diagnostic tests

Tue, 05 Sep 2006 20:01:36 -0400

The FDA is taking steps toward regulating genetic diagnostic tests. The agency has released draft guidelines of the new regulations, which supporters say should help validate the tests for consumers. On the other hand, critics maintain that the FDA's decision to step into the field will raise costs and discourage the development of new tests. Diagnostic tests sold to labs and doctors are already under the FDA's control as medical devices. But tests used at home, such as predictive tests for breast cancer, are not. The number of those "home brew" tests is expected to soar. These diagnostic tests will play a big role in the development of more personalized medicines, a specialty of the biotech industry.

- read The New York Times article on the FDA guidelines

Advocates criticize FDA advisory committees

Mon, 28 Aug 2006 20:01:36 -0400

An advocacy group is lambasting the FDA's advisory committees for being too obliging to new drug applications. The National Research Center for Women & Families says that the committees have recommended approvals in 79 percent of all cases between 1998 and 2005. The leaders of the group say that's a sign that the committees are too willing to do the drug companies' bidding. The FDA--which has been reviewing regs on who gets to serve and vote on these panels--limited itself to a bland statement that their final decisions are based on a "totality" of the information available on a therapy. It's doubtful that the critics' math would persuade many people in the drug development world, though, who can tell you quickly that getting a drug through to an FDA approval is no walk in the park.

- read the AP report on the group's results

JAMA editor won't ban authors for nondisclosure

Tue, 08 Aug 2006 20:01:38 -0400

On the advice of attorneys, the editor of the Journal of the American Medical Association says she won't ban authors who fail to disclose their financial ties to the drug industry, as a ban might spur antitrust suits. A ban "would only encourage that author to send his or her articles to another journal; it cleans our house by messing others," says Catherine DeAngelis, who has been highlighting cases of authors who fail to adhere to JAMA's disclosure rules. Critics who had been calling for a ban immediately launched new assaults on JAMA, saying it was refusing to enforce even basic standards of conduct by authors.

- here's the article on JAMA from NewsTarget.com

Poll finds problems at the FDA

Thu, 20 Jul 2006 20:01:38 -0400

A study released by the Union of Concerned Scientists has found that about 15 percent of FDA staffers polled say they've been "asked to… inappropriately exclude or alter technical information or conclusions in an FDA scientific document." In addition, 39 percent of respondents stated that the FDA wasn't "acting effectively to protect public health." The questionnaire was sent to almost 6,000 FDA workers and 997 responded.

The survey underscores critics concerns that the science isn't the only factor that informs the FDA's decisions. The agency has taken heat for the Vioxx debacle, and a head women's health official resigned in protest to the way politics interfered with science in the FDA's handling of Plan B, a controversial morning-after contraceptive. A spokeswoman for the FDA dismissed the poll, saying it was unscientific and asked leading questions.

- check out this San Francisco Chronicle article

Pfizer doc sounds off on drug development

Mon, 17 Jul 2006 20:01:36 -0400

In a discussion with The New York Times, Pfizer research chief Dr. John L. LaMattina discusses the drug giant's ups and downs and the challenges of fostering innovation in the world's largest drug company. Critics note that Pfizer's low product output could be due to increased bureaucracy and less autonomy among its researchers. But LaMattina reminds readers that in this business, success is measured in decades and that Pfizer's all-important experimental drug pipeline will deliver promising treatments in the years to come. He's optimistic that Pfizer, along with the drug industry as a whole, is entering a new age in drug development that will revolutionize medicine.

- for more, read this The New York Times article

FDA to keep doors shut on Hemopure hearing

Mon, 10 Jul 2006 20:01:36 -0400

The FDA will proceed with a closed-door hearing about a proposed non-consent trial for a blood substitute even though its developer, Biopure, has said that it has no objections to keeping it open to the public. The Navy wants to gain the agency's approval for the trial, which would test Hemopure among trauma patients unable to consent to their participation. Military officials evidently had not been able to agree on terms to make the hearing public, although some involved noted that the FDA also appeared reluctant to open up the hearing to reporters. The decision immediately sparked fresh controversy among critics.

- for more on the hearing, read this Wall Street Journal report (sub. req.)

PLUS: Biopure is seeking UK approval for Hemopure. Report

Critics cite pharmas on misuse of petitions

Sun, 02 Jul 2006 20:01:36 -0400

Some lawmakers on Capitol Hill are pushing a new measure that would limit the drug industry's use of citizen petitions to delay generic competition. Twenty of the last 21 petitions sent to the FDA in the last three years were rejected, but critics maintain the forced delay in marketing a generic competitor gained drug makers hundreds of millions of dollars. The Washington Post uses Biovail as an example. The drug maker's petition has forced a generic competitor to Wellbutrin XL into regulatory limbo, helping maintain its market for the brand-name therapy.

- here's the article from The Washington Post on petition reform

Novartis makes a $10B bet on generic drugs

Wed, 03 May 2006 20:01:36 -0400

The Wall Street Journal takes a close look at Novartis' $10 billion investment in the generic drugs business as the pharma giant's CEO, Dr. Daniel Vasella, attempts to meld rival strategies. Critics abound, but Novartis says that with more than half of all prescriptions being written for generics, it's the best way to position the company for long term growth. With some experts predicting that the generics business will almost double to $100 billion in 2010, Novartis aims to control 10 percent of the action. But even at Sandoz, Novartis' generics arm, some wonder if Novartis has an aggressive enough approach.

- read the WSJ's report on Novartis (sub. req.)

GAO cites FDA on post-market safety failure

Sun, 23 Apr 2006 20:01:39 -0400

The Government Accountability Office today lambasted the FDA for failing to create a "clear and effective process" for managing post-market drug safety. The report was ordered by Senator Charles Grassley, who suggested that the FDA's seal of approval for drug safety isn't warranted. The report was requested in 2004 as the agency was reeling from revelations about its handling of the cardiovascular dangers of Vioxx and teen suicides linked to antidepressants.

The most immediate question raised by the report was whether the Office of Drug Safety will be removed from the Center for Drug Evaluation and Research, which also includes the Office of New Drugs. Critics have called for drug safety personnel to operate separately from the group responsible for drug review. The GAO didn't make any direct recommendations, but did call on the FDA commissioner to clarify the role. The report also recommended that Congress look at requiring post-marketing studies. Currently the studies are often agreed to and regularly ignored.

- here's the report from USA Today for more information

Ruling sparks more debate on biogenerics

Sun, 23 Apr 2006 20:01:35 -0400

A recent court ruling demanding that the FDA take action on an application for a biogeneric version of a human growth hormone is forcing a fresh look at how the U.S. can start down the road to less expensive knockoffs of biotech drugs. Critics say that even subtle differences in biotech molecules can create serious risks. Others point out that insulin and human growth hormones are among the simplest molecules and are therefore most likely to lend themselves in the near term to a biogeneric competitor. The FDA, meanwhile, has dropped one biogeneric initiative and no one seems completely sure just where the agency is headed.

- read the report from the Boston Globe

Von Eschenbach nomination faces challenges

Wed, 15 Mar 2006 19:01:38 -0500

President Bush nominated Andrew von Eschenbach to the permanent post of FDA commissioner, but the nomination is in trouble from the get-go, with senate leaders vowing to hold the nomination hostage to a firm decision from the agency on making the controversial Plan B contraceptive available over the counter. Scientists at the FDA have been clear that the contraceptive is safe and effective, but top regulators have pushed Plan B into regulatory limbo. Conservatives see Plan B as a tacit encouragement to promiscuity, which some internal and external critics say shouldn't be an issue at all.

Plan B was a major snag for Lester Crawford, who left abruptly after only a brief period following his controversial nomination process. But with both sides vowing to hold on and fight to the bitter end, it's likely to be some time before von Eschenbach prevails. That is likely to continue the prolonged sense of uncertainty that has plagued the FDA during the bulk of President Bush's administration.

- read this Los Angeles Times report

EMEA Committee OKs second biosimilar

Thu, 23 Feb 2006 19:01:36 -0500

The EMEA's Committee for Medicinal Products for Human Use has given its second recommendation for an approval of a biosimilar therapy. Committee members recommended EMEA approval for BioPartners' growth-hormone Valtropin, which is a generic version of Merck's Humatrope. The Committee recently approved Omnitrope, another biosimilar growth hormone.

The European regulatory action is likely to put continued pressure on the FDA to begin addressing calls for approving biosimilars in the U.S. Biotech companies have been steadfastly opposing the idea, saying that biotech drugs are too complex to allow knockoffs. Critics say they just want to avoid the cut-rate competition. Growth hormones have been around for some time now, though, and it's unlikely that the FDA will be able to resist advancing biosimilars if the process works in Europe.

- here's the release

Drug companies enlist cheerleaders in effort to kick up sales

Sun, 27 Nov 2005 19:01:36 -0500

In the constant quest to gain an edge in the business of marketing drugs to doctors, a lineup of pharmaceutical companies have been enlisting cheerleaders into the ranks of drug reps. Experts say the ready smile, good looks and cheerful countenance of cheerleaders make them a natural for the work. And with freebies frowned on, it's one of the few remaining ways that drug companies can gain extra attention for their products. However, some critics say that this kind of marketing effort will have only limited results.

- read this article from The New York Times for more

Questionable 'me-too' drugs crowd market with expensive meds

Sun, 20 Nov 2005 19:01:37 -0500

The San Diego Union-Tribune looks at a roster of drug developers that are tweaking existing therapies and charging a premium compared to comparable generics. Case in point: Santarus' Zegerid, a heartburn medication that combines a generic ingredient with sodium bicarbonate. Critics contend that these "me-too" drugs simply waste billions of dollars and create a bad reputation for the biotech business, which prides itself on making critical advances that demand high-dollar returns to encourage expensive research.

- see this article from the San Diego Union-Tribune for more