Waxman retirement, tip of the iceberg

The Washington health policy world is headed for a major shake-up next year, as more long-time leading legislators opt for retirement. The recent announcement that Rep. Henry Waxman (D-Calif) will leave marks the end of a 40-year career on Capitol Hill, highlighted by engineering enactment of legislation that established the generic drug industry, supported treatment for AIDS and promoted development of orphan drugs.

The Senate faces even more substantial changes, with the departure of leading Democrats Max Baucus of Montana, who currently

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chairs the Finance Committee; Tom Harkin of Iowa, head of the Health, Education, Labor, and Pensions committee; and Commerce Committee chair Jay Rockefeller. They have been shaped Medicare and Medicaid programs, FDA regulatory policy and, more recently, national health reform. Their collective experience has provided a basis for bipartisan collaboration with Republicans on key legislative initiatives important for biomedical research, drug regulation, and medical product reimbursement,

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and it’s uncertain who will provide comparable leadership in the coming years.

Waxman, who currently is the top Democrat on the House Energy & Commerce Committee, previously chaired that panel and also led the House Oversight & Government Reform Committee. Also departing with Waxman is Rep. George Miller, another leading Democrat from California who helped shape current health programs as a leader of the House Education & Work Force Committee. He and Waxman came to Washington as part of the “Watergate class of 1974” and gained leadership positions that enabled them to promote important policies affecting health, education, and

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PDA Panel Proposes Limited Set of Metrics to Measure Quality Trends

If FDA is going to establish standards for assessing the quality of manufacturing sites and products, it should seek data on a few well-defined measures that reflect longer-term results and trends, rather than “snapshots of current numbers.” And such metrics should include more leading—vs. lagging—indicators to reflect a firm’s commitment to continuous improvement in production processes. Those recommendations come from a PDA “points to consider” paper, written to help FDA set standards to measure product quality and manufacturing capabilities.

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Innovation on the Rise among Indian Pharmaceutical Companies

India has a name when it comes to generic drug development. According to a recent research on patent applications carried out by Withers & Rogers, innovation by Indian pharmaceutical companies has increased over the

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past few years; however, the quality did not match the standard seen in Europe. Read more »

FDA Expands Oversight of Large Compounders

Moving fast to bolster its authority over compounding pharmacies that operate as manufacturers of prescription drugs, FDA is urging “outsourcers” to register, seeking state support, and moving to issue more rules and guidance. The agency is pleased that 14 outsourcers registered through mid-January. The number is small, considering that an estimated 3000 compounding pharmacies make sterile injectible drugs, but this initial activity reflects FDA’s fast action in implementing the Drug Quality and Security Act (DQSA), which was enacted less than three months ago.

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Conference Programs Highlight InformEx 2014

The critically acclaimed television show Breaking Bad told the tales of a high school chemistry teacher who, after a diagnosis of advanced cancer, started a methamphetamine laboratory in order to support his family. While this is not the career path the chemical industry wants to endorse, the popular show did demonstrate applied science in action. At InformEx 2014, Donna Nelson, professor of organic chemistry at the University of Oklahoma and a scientific advisor for the program, will discuss her role in the program.

However, InformEx 2014, scheduled for Jan. 21-24 in Miami Beach, Fla., also features more mainstream conference topics. Conference programs are scheduled for Jan. 22-23 and will be located on the show floor. Exhibits are open Jan. 21-24.

The scheduled topics include an analysis of the current state of the pharmaceutical industry, where growth may come from, what new molecules may look like, and services drug manufacturers may require.

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studies, challenges encountered in formulation development and manufacture of clinical trial material when moving from Phase 1 to Phase 2 and 3 studies. Participants can also learn how pharmaceutical companies and CDMOs are aligning sustainability policies and how these programs can generate a significant return on investment.

Other sessions will address vulnerabilities in the chemical supply chain, intellectual property protection, recent advances in chemical technologies for the synthesis of glyochemicals and glycoconjugates, creating value in partnerships between pharma and technology providers, and market opportunities in personalized medicine for the fine, custom and specialty chemicals industry.

On Tuesday, Jan. 21, a full day of exhibitor technology showcases are scheduled.

Networking breakfasts, as well as the InformEx 30th Edition Celebration, provide opportunities for interaction.

More than 3,500 attendees from top pharmaceutical, fine chemical and specialty chemical companies — along with 450 exhibitors — will take part in InformEx 2014, organizers report.

If you are in attendance, please visit Pharmaceutical Technology at booth 1321.

FDA Approves Fewer New Drugs, But Acts Fast on Innovative Products

As expected, FDA approved only 27 new molecular entities (NMEs) in 2013. There was no late-December surge in approvals to bring the tally closer to the near record of 39 innovative new drugs approved in 2012. In addition, the Center for Biologics Evaluation and Research (CBER) approved eight novel products, including innovative influenza vaccines and a number of blood products.

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Most-Read News Stories of 2013

While the Affordable Care Act, Pope Francis, and the government shutdown were top general news stories in 2013, the bio/pharmaceutical industry had its own headlines. Pharmaceutical Technology analyzed the hundreds of news stories published in 2013, and found the top 10 most-read articles, based on reader clicks. To no surprise, the most-read articles reflect major bio/pharmaceutical business announcements and regulatory activity.

Merck Cuts 8,500 Positions, Moves Headquarters

Scientist Jailed for Falsifying Research Data

FDA Lists Guidance Documents Planned for 2013

Ben Venue Laboratories Enters Consent Decree

FDA Releases SUPAC Guidance

AstraZeneca Announces an Additional 2300 Layoffs

Hameln Pharmaceuticals Receives FDA Warning Letter

Novartis Receives FDA Warning Letter for cGMP Violations at Austrian Plant

Pfizer Voluntarily Recalls Levoxyl

AstraZeneca to Cut 1600 Positions in R&D Reorganization

To stay on top of pharmaceutical industry news in 2014, subscribe to a Pharmaceutical Technology newsletter.

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Provider Demand to Drive Compounder Registration with FDA

FDA is moving fast to implement the drug compounding provisions of the new Drug Quality and Security Act (DQSA), issuing new guidance to spur registration by outsourcing facilities just days after President Obama signed the new bill into law. Because FDA cannot compel compounders to opt for agency regulation, implementation will rely largely on market pressures to encourage healthcare providers to purchase compounded products only from registered facilities, explained FDA commissioner Margaret Hamburg at a press briefing Dec. 2, 2013.

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Where Is the Vaccine for Meningitis B?

The bacterial meningitis outbreak at Princeton University in recent weeks has raised questions about why there is no vaccine in the United States to prevent this deadly disease, when such a therapy is approved in Europe and Australia. The current Princeton health danger prompted the Centers for Disease Control and Prevention (CDC) to request emergency import of the vaccine, and the Food and Drug Administration approved that move, authorizing an investigational new drug application (IND) for Novartis’ Bexsero vaccine. New reports of additional meningitis B cases in California may spark further discussion about ensuring US access to protection against this dangerous infection.

The situation illustrates the complexities of vaccine development, approval and reimbursement at home and abroad. Studies to document vaccine safety usually require testing in thousands of healthy individuals, plus certain high-risk populations. There are four meningitis vaccines licensed in the US, but they protect against four other meningococcal disease strains, and not B, which has proven more difficult to attack.

Moreover, meningitis B is not that prevalent in the US, so Novartis and other vaccine makers have concentrated clinical trials for B preventives in Europe, Australia, and other regions. The resulting study data supported market approval for Bexsero in the European Union in January 2013 and more recently in Australia. More trials have been launched in Latin America and even Canada, but not in the US where Novartis did run a small, early trial on adolescents several years ago. Meningitis is most deadly in infants and very young children, and testing in those populations raises difficult risk-benefit calculations for a relatively uncommon condition.

In April 2011, the FDA advisory committee on vaccines and related biological products discussed the effectiveness of meningococcal vaccines in young children and approaches for demonstrating effectiveness in serogroup B vaccines. Representatives from Novartis and Pfizer made presentations on new but differing approaches for developing effective therapies and new surrogates for demonstrating protection.

Novartis says it is discussing a “pathway to licensure” with FDA and “evaluating its phase 3 plans” for the US and other regions. But market approval of a meningitis B vaccine in the US may take much longer because Novartis and other vaccine makers now appear more interested in developing a combination vaccine that will cover all five meningitis strains.

To some extent, that decision reflects problems with reimbursement for new vaccines, which largely comes from public health agencies. Novartis received a blow in July when the UK’s Joint Committee on Vaccination and Immunisation advised against adding Bexsero to its routine vaccination program. The Committee is reconsidering that recommendation, which was based largely on cost-benefit considerations: whether it is worth the money to vaccinate some 800,000 infants a year when only 1800 cases of the disease are found in children in the UK each year, and there are concerns that the vaccine may be only 73% effective.

These developments have spurred more talk about Novartis selling its vaccine business, which has struggled to be profitable, according to market analysts. Novartis recently announced the sale of its blood transfusion diagnostics unit, which is housed with its vaccines unit.

Researchers and patient advocates for a more effective meningitis vaccine point out that cost-effectiveness studies often fail to assess prevention appropriately. They also fear that a final UK non-coverage decision for Bexsero could discourage vaccine research in general. Coverage certainly would be easier to justify for an all-strain meningitis vaccine, but that may involve years of more testing.

Senate Finalizes Drug Compounding, Tracking Legislation

Congress gave final approval this week to new legislation to strengthen FDA authority to oversee large pharmacy compounders of sterile injectables and to require more comprehensive tracking of prescription drugs moving through the global supply chain. The House passed the the Drug Quality and Security Act in late September, but Senate action was delayed, first by the federal government shut-down in October and then by individual efforts to force a vote related to Obamacare.

But continued public outrage over deaths from contaminated injectables produced by large compounding pharmacies, along with rising concerns about counterfeit and unauthorized drugs entering the US market, managed to overcome the partisan stalemate on Capitol Hill to win strong approval for the measure. No one gets all they wanted from the legislation, but it provides more clarity and predictability to drug oversight programs and moves forward initiatives designed to enhance the safety and quality of medicines in the United States.

Alan Coukell, senior director of drugs and medical devices at The Pew Charitable Trusts, praised the bill as “meaningful” and said that efforts to block counterfeit and contaminated drugs will “help protect lives and alleviate these costs by ensuring that prescription drugs are safe, effective and of the highest quality.”  President Obama is expected to sign the bill fairly quickly

Voluntary system
As previously noted here, the first section of the bill clarifies FDA’s authority over drug compounding, which resolves questions raised by diverse federal court rulings on the issue. Pharmaceutical manufacturers gained legislative language specifying that compounders cannot produce drugs that are “essentially a copy of a marketed drug.” But the bill is not as strong as FDA and patient advocates had hoped, as it fails to set specific criteria to differentiate large commercial operations from local compounding pharmacies. The legislation instead relies on a voluntary registration system for large-scale compounders, which will have an impact only if large purchasers of compounded drugs insist that their suppliers meet FDA standards.

Pre-empting states
The main gain for manufacturers from the drug supply chain security section of the act is to pre-empt state pedigree laws, including the comprehensive California statute slated to go into effect in 2015. The new bill generally follows the Senate’s 10-year time-line for establishing an electronic, interoperable, unit-level drug tracking system. All drug packages will have to carry serial numbers in four years, and FDA will establish verification and traceability standards and provisions for data exchange.

The tracking system will include manufacturers, wholesaler/distributors and pharmacies, with some exceptions for small firms. In addition, third-party logistics providers such as Federal Express and UPS get a pass on keeping records and participating in investigations, which could create serious gaps in the tracking process.

Some critics blasted the bill for giving industry so much time to establish unit-level tracking and for imposing fairly weak oversight of compounders. But FDA, manufacturers, and policy makers seem pleased to gain enactment of any legislation at all. The long-term impact remains to be seen.

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