This long-awaited conclusion marks the end of months speculation by investors and media and back-and-forth between the companies. Taking a look back, in early July 2010 PharmTech blogger Patricia Van Arnum reported on rumors of sanofi looking to acquire a US-based company for the price of rougly $20 million. By the end of July, the buzz was that sanofi would be targeting Genzyme, and unconfirmed reports speculated that sanofi was close to making an unsolicited $18-billion bid, or $70 per share, as I mentioned in a blog post.

The rumors continued throughout August and posts by Stephanie Sutton and Erik Greb shared collected bits and pieces of details about the situation. Various sources and analysts had differing expectations for the deal, such as that Genzyme would take no less than $80 per share. By the end of the month, an official offer letter from sanofi to Genzyme had been announced with an offer of $69 per share. It was promptly rejected by Genzyme.

In October, sanofi made a tender offer of the same price and Genzyme advised shareholders to reject the offer. In November and December of last year, the company issued statements reiterating its position on the tender offer. When fewer than 1% of shares were tendered in early December, sanofi decided to extend the offer another six weeks to Jan. 21, 2011.

Both companies issued statements in early January, and sanofi said the possibility of CVRs and an offer was explored, as well as the potential of Lemtrada. Genzyme confirmed the discussions in a statement. As Stephanie Sutton wrote, the current opinion among analysts was that sanofi would pay $76 per share for Genzyme. When Genzyme announced that it was allowing sanofi to conduct due diligence on Jan. 31, many thought it was only a matter of time until a conclusion to the negotiations was formed and the deal considered a success. Now, after seven months, the companies have reached an agreement.

See related PharmTech articles:

The Latest Sanofi/Genzyme Rumors

Success Is Unlikely on sanofi’s Terms

Genzyme Steals Headlines Again

Sanofi’s Courtship of Genzyme in Limbo

A Turning Point for Genzyme?

Will Sanofi Bag Genzyme?

Is sanofi-aventis On the Acquisition Path?

At the time of my blog post from last week, the survey had received roughly 130 responses and 90% of readers had voted “Yes.” The final count for the poll was a total of 211 respondents, with 86% voting in favor of expanding FDA’s authority.

These results show that the idea of granting FDA mandatory drug recall authority has more support from PharmTech.com voters than it did in June, when we initially asked the question. In June, 72% voted “yes,” compared with the recent poll, which had 50% more respondents, that featured 86% voting favorably. Perhaps the increase in “yes” votes is due to FDA recently gaining the ability to issue mandatory food recalls under the FDA Food Safety Modernization Act, signed into law early last month. We’d like to hear from you—why do feel that the agency should or should not have drug-recall authority?

PharmTech is asking readers in our current poll whether FDA should have the same power over pharmaceutical recalls. Right now, nearly 90% of respondents have said  “Yes.”

We asked the same question back in June 2010, after US House Oversight and Government Reform Committee Chairman Edolphus Towns announced in his closing statement at the first hearing on Johnson & Johnson’s children’s medicines recall that he planned to introduce legislation to give FDA mandatory recall authority. At that time, 72% of respondents thought that the agency should have the power to do so.

Our current poll has about the same number of respondents as the poll from June. It will remain open until Wednesday, so the 90% majority could change. Perhaps the final results will be similar to those of last year’s poll. Or perhaps opinions are shifting in favor of allowing tighter regulation by FDA. Could J&J’s recent massive recalls have changed people’s minds? Luckily, the company’s widespread recalls of its over-the-counter products were, as the company states in most of the recall notices, “not being undertaken on the basis of adverse medical events,” and that the possibility of such events is remote. Perhaps to protect the safety of the OTC and pharmaceutical drug supply, FDA should have more power.

US House Reps. John D. Dingell, chairman emeritus of the Energy and Commerce Committee; Henry A. Waxman, chairman of the Energy and Commerce Committee; Frank Pallone, chairman of the Subcommittee on Health; and Bart Stupak, chairman of the Subcommittee on Oversight and Investigations introduced last December H.R. 6543, The Drug Safety Enhancement Act, which would expand FDA’s authority to provide it with more resources to ensure drug safety. One provision of the bill would give FDA new enforcement tools, such as mandatory recall authority, increased civil and criminal penalties, and new FDA authority to subpoena records related to possible violations of supply-chain safety.

“In recent years, our domestic drug supply has become an increasingly globalized one,” Rep. Waxman said in an announcement of the bill.  “Unfortunately, FDA lacks the proper authorities and enforcement tools to help fully protect us from the new threats posed by this system, as illustrated by the heparin catastrophe of 2007. This legislation will provide the tools and resources the agency needs to do just that.”

Cast your vote in PharmTech’s current poll, and feel free to comment below why you voted for or against granting FDA drug-recall authority.

Each December, we have posed the question, “What area of the pharmaceutical industry do you think will experience the most change in 2011?” in our reader poll on PharmTech.com. For 2011, you told us that the area to undergo the most change will be the outsourcing and consulting segment. In a similar pattern to the pharma forecast for 2010, you said that regulation policy and enforcement would also face many changes, and that drug-delivery methods and formulation development and manufacture would see modest activity.

Looking back at previous results, analytical testing and packaging and labeling are consistently seen by readers taking the poll as the areas that are least likely to change much during the coming year. You have also voted that you don’t expect to information technology to be the most variable category in a given year.

Take a look at the results from the past few years:

Pharma Forecast for 2011

Pharma Forecast for 2010

Pharma Forecast for 2009

Pharma Forecast for 2008

You can look at past questions and results in our Poll Archive. Our current poll focuses on granulation techniques; click here to cast your vote.

Congress passed the FDA Food Safety Modernization Act last week, and President Obama is expected to sign the bill into law soon. The Act revamps FDA’s authority over food safety and includes the following key points:

• It allows FDA to establish and enforce a prevention-based approach to food safety, requiring food facilities to keep a written plan of possible problems and solutions.
• FDA gains the ability to hold food companies accountable for preventing contamination.
• It outlines a risk-based approach to inspections of food-processing facilities, as well as increasing the frequency of inspections.
• It strengthens the safety of imported foods by giving FDA more authority over importers and enforcement of food-safety requirements.
• Finally, it gives FDA the authority to issue mandatory recalls. The agency said in a statement, “While FDA expects that it will only need to invoke this authority infrequently since the food industry is largely compliant with FDA’s requests for voluntary recalls, this new authority is a critical improvement in FDA’s ability to protect the public health.”

FDA Commissioner Margaret A. Hamburg issued a statement last Tuesday supporting the legislation, saying, “This law makes everyone responsible and accountable at each step in today’s global food supply chain.”

Drugs could be next
A bill was introduced in the House on Dec. 17, 2010, that focuses on expanding FDA’s authority and providing it with the proper resources to ensure the safety of pharmaceutical products. Reps. John D. Dingell, chairman emeritus of the Energy and Commerce Committee; Henry A. Waxman, chairman of the Energy and Commerce Committee; Frank Pallone, chairman of the Subcommittee on Health; and Bart Stupak, chairman of the Subcommittee on Oversight and Investigations, introduced H.R. 6543, The Drug Safety Enhancement Act. Among the provisions of the bill is the power to enforce mandatory recalls.

The topic of granting FDA this authority was recently discussed during the second Congressional hearing on Johnson & Johnson’s recalls. FDA Deputy Commissioner Joshua Sharfstein said during his testimony to the The House Committee on Oversight and Government Reform that there is a need to rethink the current system of voluntary recalls and that the agency should have the ability to initiate drug recalls. A poll conducted on PharmTech.com in June showed that 72% of readers think FDA should have this authority. Perhaps now that the agency is close to gaining the power to recall food, increased pressure will force lawmakers to reconsider expanding that authority to pharmaceuticals as well.

As stated on Rep. John D. Dingell’s website, H.R. 6543 also:

• Creates an up-to-date registry of all drug facilities—both foreign and domestic—serving American consumers
• Generates funding for increased Good Manufacturing Practices (GMP) inspections for brand and generic drugs
• Requires parity between foreign and domestic inspections
• Prohibits entry of drugs coming from domestic and foreign facilities that limit, delay or deny FDA inspections
• Prohibits the entry of drugs into the US lacking documentation of safety
• Requires manufacturers to know their supply chain, identify and mitigate risk throughout their supply chain, and to document measures taken to secure their supply chain
• Prohibits false or misleading reports to FDA
• Provides strong new enforcement tools, including mandatory recall authority, increased civil and criminal penalties, and new FDA authority to subpoena records related to possible violations
• Provides protection for whistleblowers that bring attention to important safety information
• Requires unique identification numbers for drug establishments and importers to improve the ability of the FDA to more quickly identify parties involved in a crisis situation.

After introduction two weeks ago, the bill was referred to the House Committee on Energy and Commerce.

If FDA approves Contrave, it will become the first new prescription weight-loss treatment in more than a decade. The agency, which isn’t required to follow the advice of its expert panels but usually does, is set to decide on the drug’s status by Jan. 31, 2011.

This week, FDA personnel met with executives from Arena Pharmaceuticals (San Francisco), developer of the rejected obesity drug lorcaserin, and outlined a plan for the company to resubmit its new drug application and seek future approval. Arena President and CEO Jack Lief said in a company statement that the company expects to refile the NDA by the end of 2011.

In September, lorcaserin was rejected, in a 9–5 vote, by the panel because of concerns that early testing showed mammary tumors in rats. In October, Arena said in a press statement that FDA’s complete response letter (CRL) stated concerns about the tumor risks, as well as the drug’s efficacy, stating that the weight-loss experienced by people without Type 2 diabetes in clinical trials was marginal.

Qnexa (phentermine/topiramate) by Vivus (Mountain View, CA) was also rejected (in a vote of 10–6) by FDA’s committee in July because of health risks, specifically, concerns about cardiovascular problems and birth defects. Vivus said last week that it submitted a briefing document to FDA to address the agency’s concerns in its CRL, and will meet with FDA’s endocrine and metabolic division in January to discuss resubmission possibilities.

On Monday, Vivus began the approval process for Qnexa in Europe by filing a marketing authorization application with the European Medicines Agency. The company said the drug could receive approval late next year.

See related PharmTech articles:
Safety Concerns Prompted FDA’s Rejection of Qnexa and Lorcaserin

FDA Panel Votes ‘No’ on Arena’s Obesity Drug

FDA Mulls More Obesity Drugs

The manufacturing plant was closed in April following massive recalls of more than 40 types, and 135 million bottles, of infants’ and children’s medicines on April 30, 2010, due to contamination and substandard quality. The April 30th recall was also the subject of a hearing by the House Committee on Oversight and Government Reform in May. J&J responded by presenting an action plan to FDA in July outlining how to improve product quality. The company also appointed a corporate head of quality in August that reports directly to the CEO.

The company has issued numerous additional recalls related to product quality in the past year, the most recent was the last week’s voluntary recall of Rolaids products after consumer reports found wood and metal particles in the tablets.

McNeil has also had problems with quality in Puerto Rico. In January 2010, FDA issued a Warning Letter to McNeil for “significant violations of the Current Good Manufacturing Practice (CGMP) regulations” at its facility in Sector Montones, Las Piedras.

Executive Appointments
J&J expanded the office of the chairman Wednesday by adding two new positions. The company appointed Alex Gorsky, currently worldwide chairman of medical devices and diagnostics, and Sheri McCoy, currently worldwide chairman of pharmaceuticals, to the positions of vice-chairmen of the executive committee, effective Jan. 3, 2011. Gorsky will have the added responsibilities of the medical device and diagnostics group, global supply chain, and government affairs and policy. McCoy will oversee the pharmaceuticals group, consumer group, the corporate office of science and technology, and corporate affairs.

“These appointments will ensure we are well-positioned for sustainable growth into the future,” said William C. Weldon, chairman and CEO. “The changes are an appropriate step in furthering our long-term succession plans, and assuring talented, experienced leaders at all levels of the organization.”

The move appears to indicate that the beginnings of a succession plan is in place—the New York Times and other news outlets are calling the two promotions a “horse race” to determine who will take over as CEO. Although Weldon has faced criticism for his handling of the company’s recent quality problems and pressure to step down from his position, a company spokeswoman told NYT that Weldon “has no plans to retire.”

Click here to view a list of previous PharmTech blog posts about J&J.

In India, Delhi Chief Minister Sheila Dikshit promised earlier this week to fight the public health threat of counterfeit drugs. Speaking at a seminar on combating counterfeit drugs, she urged a policy of zero tolerance toward them, according to an article from The Times of India.

Dikshit’s action plan calls for improved testing of suspected counterfeit drugs and increased vigilance against fakes among pharmacists and regulatory agencies. It also recommended that the State Drug Control Department be strengthened and should focus on halting the spread of counterfeit medicines.

“It is also the need of the hour to have an adequate testing laboratory to ensure that the suspected samples are tested expeditiously,” she said. Dikshit urged pharmacists to ensure that their sources of pharmaceuticals are safe. Establishing a toll-free helpline to receive complaints of suspected counterfeit drugs was also proposed.

These measures launched by China and India will be good steps toward eliminating the spread of illegal fake goods and pharmaceuticals. Because of the growing problem of counterfeits, more efforts will be needed to make strides in eliminating them to protect the health of consumers and the business interests of pharmaceutical companies.

In both cases, FDA followed the advice of the Endocrinologic and Metabolic Drugs Advisory Committee, which recommended that the two drugs, Qnexa (phentermine/topiramate) by Vivus (Mountain View, CA) and lorcaserin hydrochloride by Arena Pharmaceuticals (San Diego), not be approved because of health risks. In the CRL for Qnexa, FDA requested more study results and information about the drug’s risks such as cardiovascular events and birth defects, according to Vivus. Arena announced that FDA’s main concerns with lorcaserin were that early testing showed mammary tumors in rats, and that the weight-loss experienced by people without Type 2 diabetes in clinical trials was marginal. FDA asked for more data and said more clinical testing may be required if concerns about the tumors are not alleviated.

Another setback for obesity treatments was the voluntary recall of Meridia (sibutramine) in the US and Canada by Abbott (Abbott Park, IL) in October. FDA requested the recall due to risks of stroke and cardiovascular side effects. Meridia was banned in Europe in January.

There is hope, however, for approval of a third new treatment. Contrave (naltrexone sustained release [SR]/bupropion SR), by Orexigen Therapeutics (San Diego), will face the advisory committee early next month, on Dec. 7. FDA will decide by Jan. 31, 2011 whether to approve the drug.

See related articles:
FDA Panel Votes ‘No’ on Arena’s Obesity Drug

FDA Mulls More Obesity Drugs

Ghana
Regulators in Ghana last week found that substandard and counterfeit versions of 13 antimalarial drugs were in use in sites across the nation. The discovery of the fake medicines was made possible by the Medicines Quality Monitoring surveillance program, which is a collaboration between the Ghana Food and Drugs Board (FDB), the US Pharmacopeial Convention (USP), and the US Agency for International Development (USAID). The program was established in 2008 and is implemented by USP’s Promoting the Quality of Medicines (PQM) initiative, which aims to improve the drug quality in developing countries.

A recall of the antimalarial drugs was initiated, and the names of the outlets where the drugs were uncovered were publicized. According to a USP press statement, the release of those locations was “intended as a strong deterrent, making pharmacy and hospital procurement personnel more vigilant about their suppliers.”

Patrick Lukulay, director of the PQM program, said, “It’s important to keep in mind that all these fake and substandard medicines were found just in one round of postmarket surveillance, just of antimalarials. The existence of many more substandard and counterfeit medications for other types of medicines and in other locations and facilities must be assumed. Public education and official collaborations between public and private sectors are both essential to protecting public health here in Ghana and in many other developing nations.”

Liberia
Liberia established a new regulatory authority to oversee the country’s medicines by signing into law the Liberia Medicines and Health Products Regulatory Authority (LMHRA) Act earlier this month. The legislation addresses the growing problem of substandard and counterfeit drugs in the nation’s market, according to a USP press release. USP’s PQM found that postmarketing sampling and testing that the organization conducted in March 2010 revealed a failure rate of 44% when 104 of 234 samples tested failed either simple disintegration, thin-layer chromatography, or both.

“We celebrate this important milestone in the history of the pharmaceutical sector of our country,” Reverend Tijli Tarty Tyee, Sr., chief pharmacist of the Republic of Liberia, said in the press release. “We believe that the implementation [of this Act] will be the most important aspect of the law that can ensure the protection of the citizens within our borders.”

Zambia
A pharmacist in Zambia called on the government last week to empower regulators to help fight the spread of counterfeit drugs. According to an article in the Zambia Post, Christopher Sakala said in a presentation during the Stop Stockout Campaign anticounterfeiting seminar in Lusaka that the country’s Pharmaceutical Regulatory Authority needs more inspectors, saying that five for the entire country conducting inspections at two entry points is simply not enough.

“The Pharmaceutical Regulatory Agency needs to be equipped properly. It is a professional body that works very hard to check on the quality of medicines the Zambian patients consume. This is a body that is serious with issues of public health, but they work under difficult conditions,” Sakala said.

He also advised health institutions to employ licensed pharmacists to distinguish between legitimate and counterfeit drugs.

See related PharmTech articles:

USP and USAID Launch New Program to Improve Drug Quality

Sproxil’s Mobile-Phone Technology Tracks Medical and Food Donations, Prevents Diversion

An International Web May Trap Pharma Counterfeiters, but It Won’t Keep Them for Long

When Substandard Drugs and Developing Nations Collide